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LY18An Open-Label Phase I Dose-Escalation Study of Venetoclax in Combination with Rituximab, Gemcitabine, Dexamethasone and Cisplatin in Patients with Relapsed or Refractory Diffuse Large B cell Lymphoma
An Open-Label Phase I Dose-Escalation Study of Venetoclax in Combination with Rituximab, Gemcitabine, Dexamethasone and Cisplatin in Patients with Relapsed or Refractory Diffuse Large B cell Lymphoma

Complexity Level: 2

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, (514) 340-8207


Planned
ALC4 (ECOG E1910)A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults.
A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults.

Complexity Level: 1

Eligibility: Adults aged 30-70 years with confirmed new diagnosis of BCR-ABL negative, B-lineage ALL.

Objectives: Primary: to evaluate the overall survival associated with blinatumomab Secondary: minimal residual disease assessment; toxicities associated with treatment; outcome of blood/marrow transplant with or without blinatumomab; incidence of anti-blinatumomab antibody formation

NCT Registration ID (from clinicaltrials.gov): NCT02003222
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: March 24, 2017

Chair: (Canada) Dr. Julie Bergeron, Hopital Maisonneuve-Rosemont, (514) 252-3400 Ext. 3404


Open to Accrual
LY17A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma
A Multi-stage Randomized Phase II Study of Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma

Complexity Level: 2

Eligibility: Patients with relapsed and refractory aggressive B cell lymphoma (includes diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and T-cell rich B-cell lymphoma, as well as transformed previousl indolent lymphoma and unclassifiable B-cell lymphoma), with clinically and/or radiologically measureable disease. Patients must be 16 years old or older, must have had at least one previous regimen of therapy for their disease, and must be considered fit for intensive chemotherapy and ASCT. Patients must have a life expectancy of >90 days, and a performance status of 3 or less. Specific laboratory requirements also apply.

Objectives: To determine the overall response rate (complete and partial response) to novel combination therapy in patients with relapsed and refractory aggressive B cell lymphoma.

NCT Registration ID (from clinicaltrials.gov): NCT02436707
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: May 05, 2015

Chair: (Canada) Dr. John Kuruvilla, University Health Network, (416) 946-2827, (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Open to Accrual
AL5 (DFCI 06-254)Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial
Dana Farber Cancer Institue (DFCI) Acute Lymphoblastic Leukemia (ALL) Adult Consortium Trial: Adult ALL Trial

Complexity Level: 1

Eligibility: Eligibility: All adults aged 18 to 50 years with newly diagnosed ALL will be eligible for this protocol. Patients with ALL-L3 will not be eligible for this study.

Objectives: Primary: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. The primary endpoint of this study is the feasibility of the intensification therapy, measured as the percentage of patients who, having achieved a CR after induction therapy, receive more than 25 weeks of IV PEG asparaginase as part of intensification therapy. To explore the relative toxicity of IV PEG asparaginase. To explore the relative efficacy and toxicity of adding imatinib to multiagent chemotherapy for patients with Philadelphia-positive ALL.

NCT Registration ID (from clinicaltrials.gov): NCT01005758
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 10, 2008 Closing Date: January 08, 2013

Chair: (Canada) Dr. Julie Bergeron, Hopital Maisonneuve-Rosemont, (514) 252-3400 Ext. 3404


Closed to Accrual
ALC2 (CALGB C10603)A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PK412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML).
A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PK412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML).

Complexity Level: 1

Eligibility: Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification, excluding M3 (acute promyelocytic leukemia); Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol-designated FLT3 screening laboratory; Age 18 and < 60 years; No prior chemotherapy for leukemia or myelodysplasia with the following exceptions: emergency leukapheresis; emergency treatment for hyperleukocytosis with hydroxyurea for 5 days; cranial RT for CNS leukostasis (one dose only); growth factor/cytokine support. AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic (including azacitidine or decitabine) therapy for MDS; Patients who have developed therapy related AML after prior RT or chemotherapy for another disorder or cancer are not eligible; Patients with symptomatic congestive heart failure are not eligible; Bili < 2.5 UNL; Non-pregnant and non-nursing.

Objectives: Overall Survival Complete response rate in remission induction, event-free survival, disease-free survival and the DRS rate one year after completing maintenance

NCT Registration ID (from clinicaltrials.gov): NCT00651261
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 21, 2009 Closing Date: October 14, 2011

Chair: (Canada) Dr. Joseph Brandwein, University of Alberta Hospital (UAH), (780) 407-7482


Closed to Accrual
ALC3 (SWOG S1203)A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

Complexity Level: 1

Eligibility: Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML).

Objectives: Primary:event-free survival; feasibility of completing an allogeneic hematopoietic cell transplantation in 60% or more of patients in frist complete remission.

NCT Registration ID (from clinicaltrials.gov): NCT01802333
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 10, 2013 Closing Date: November 04, 2015

Chair: (Canada) Dr. Mary Lynn Savoie, Tom Baker Cancer Centre, (403) 944-1564


Closed to Accrual
CL3 (CALGB C10404)A Genetic, Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations For Patients with Symptomatic Previously Untreated Chronic Lymphocytic Leukemia
A Genetic, Risk-Stratified Randomized Phase II Study of Four Fludarabine/Antibody Combinations For Patients with Symptomatic Previously Untreated Chronic Lymphocytic Leukemia

Complexity Level: 2

Eligibility: B-cell chronic lymphocytic leukemia (CLL); Creatinine less than or equal to 1.5 x ULN; Lymphocytosis > 5,000/uL with less than 55% prolymphocytes; Bone marrow aspirate with > 30% of all nucleated cells being lymphoid or bone marrow core biopsy must show lymphoid infiltrates compatible with marrow involvement by CLL; Overall cellularity must be normocellular or hypercellular; Monoclonal B-cell population that is positive for >/= 1 B-lineage markers (CD19, CD20, CD23) with co-expression of CD5 (bright surface immunoglobulin patients must co-express CD23): Symptomatic and active intermediate risk (lymphadenopathy and/or hepatosplenomegaly) or high risk (Hgb less than 11 g/dL or platelets less than 100,000/uL) category of modified Rai staging system; No prior therapy for CLL; No medical condition requiring chronic use of oral corticosteroids; Age >/= 18 years; Performance Status 0 - 2; HIV patients may be eligible if the criteria are met; Non-pregnant and non-nursing

Objectives: Progression free survival

NCT Registration ID (from clinicaltrials.gov): NCT00602459
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 13, 2009 Closing Date: August 17, 2012

Chair: (Canada) Dr. Stephen Couban, QEII Health Sciences Centre, (902) 473-8562


Closed to Accrual
CLC2 (ALLIANCE A041202)A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (> = to 65 years of age) with Chronic Lymphocytic Leukemia (CLL).
A Randomized Phase III Study of Bendamustine plus Rituximab versus Ibrutinib plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (> = to 65 years of age) with Chronic Lymphocytic Leukemia (CLL).

Complexity Level: 2

Eligibility: Intermediate or high-risk Rai stage chronic lymphocytic leukemia. Patients must be age 65 or older and have not received previous treatment for CLL.

Objectives: To determine whether progression free survival (PFS) is superior after therapy with bendamustine in combination with rituximab, ibrutinib alone, or ibrutinib in combination with rituximab in patients age 65 or older with previously untreated CLL

NCT Registration ID (from clinicaltrials.gov): NCT01886872
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 05, 2015 Closing Date: May 01, 2016

Chair: (Canada) Dr. Carolyn Owen, Tom Baker Cancer Centre, (403) 521-3621


Closed to Accrual
CLC2EA Prospective Economic Analysis of NCIC CTG CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia
A Prospective Economic Analysis of NCIC CTG CLC.2/ALLIANCE A041202: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab versus Ibrutinib Plus Rituximab versus Ibrutinib Alone in Untreated Older Patients (>= 65 Years of Age) With Chronic Lymphocytic Leukemia

Complexity Level: 3

Eligibility: All Canadian patients registered to CLC.2

Objectives: To determine the incremental cost-utility ratio, as measured in cost per quality-adjusted life-years gained, of ibrutinib-containing regimens compared to bendamustine-rituximab in elderly patients with CLL (Canadian subset of patients). The primary analysis will compare ibrutinib-rituximab with bendamustine-rituximab.

NCT Registration ID (from clinicaltrials.gov): NCT02414022
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: March 13, 2015 Closing Date: May 01, 2016

Chair: (Canada) Dr. Matthew Cheung, Odette Cancer Centre, (416) 480-5000 Ext. 4757


Closed to Accrual
HD8 (EORTC 20012)BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin's lymphoma
BEACOPP (4 cycles escalated + 4 cycles baseline) versus ABVD (8 cycles) in stage III & IV Hodgkin's lymphoma

Complexity Level: 2

Eligibility: Patients with histologically documented Hodgkin's lymphoma/disease, except for the subtype lymphocyte predominant, nodular type (nodular paragranuloma). Patients must be clinical stage III or IV and have at least one bi-dimensionally measurable target lesion. Patients with extranodal disease only will be eligible if they have at least one bi-dimensionally measurable extranodal lesion.

Objectives: The primary end point is Event-Free-Survival (EFS), also called Time to Treatment Failure or Freedom From Treatment Failure (FFTF). For this end-point, an "event" is defined as early discontinuation of protocol treatment, absence of CR after 8 cycles, relapse, progression or death. The secondary endpoints are: complete response (CR), disease free survival (DFS) in CR patients, overall survival (OS), quality of life (QoL), occurrence of second malignancies and cost effectiveness.

NCT Registration ID (from clinicaltrials.gov): NCT00049595
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: May 13, 2003 Closing Date: January 08, 2010

Chair: (Canada) Dr. Ralph Meyer, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9711 Ext. 63004


Closed to Accrual
I216Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia
Phase II Study of Buparlisib in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia

Complexity Level: 2

Eligibility: Patients with previously documented CLL that is recurrent or relapsed after previous therapy and that requires treatment. Patient must have at least one of the following: lymphocyte count >or= 10 x 10/9/L OR at least one pathologically enlarged lymph node (>or= 2 x 2 cm) by CT scan. Patients must have received at least 1 prior systemic treatment regimen (single agent or combination therapy) and recovered from all reversible toxicity related to prior chemotherapy and have adequate washout period. ECOG 0-2. At least 14 days since major surgery and 21 days since prior radiation therapy.

Objectives: To determine the overall response rate (complete + partial response). To evaluate the safety and tolerability of buparlisib. To evaluate additional measures of efficacy including duration of response rate and progression free survival. To explore potential molecular factors which may be prognostic or predictive of response or of relapse including: correlation between clinical response and MTT assay in B-CLL exposed ex-vivo to buparlisib; correlation between response to buparlisib and western blot and flow cytometry analysis of key proteins involved in the PI3K pathway; identification of mechanisms of resistance among patients who relapse after therapy with buparlisib; to prospectively validate a survival prediction scale.

NCT Registration ID (from clinicaltrials.gov): NCT02340780
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: January 30, 2015 Closing Date: January 24, 2017

Chair: (Canada) Dr. Sarit Assouline, The Jewish General Hospital, (514) 340-8207


Closed to Accrual
LY12A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R) -GDP VS (R) -DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab Versus Observation.
A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R) -GDP VS (R) -DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab Versus Observation.

Complexity Level: 2

Eligibility: Patients to be included are those with a diagnosis of aggressive histology (B cell or T cell) non-Hodgkin's lymphoma whose disease is refractory to or relapsed after one prior first-line, anthracycline-containing chemotherapy regimen. Patients with CD20+ve B cell disease will be further evaluated after completion of protocol salvage treatment and autologous stem cell transplant (ASCT) for randomization to either maintenance rituximab or observation alone.

Objectives: Randomization 1, Salvage Treatment [(R)-GDP vs (R)DHAP]. Primary: to compare response rates between the two salvage groups after two cycles of either (R)-GDP or (R)-DHAP; to compare the transplntation rate of the two salvage regimens. Secondary: to compare between the two arms event-free survival and overall survival, successful mobilization rates, quality of life, toxic effects, resource utilization, and medical/societal costs. Randomization 2, Maintenance (rituximab vs observation). Primary: to compare two-year event-free survival between the two maintenance groups. Secondary: to compare between the two arms two-year overall survival and toxic effects.

NCT Registration ID (from clinicaltrials.gov): NCT00078949
Participation: Not limited.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: August 07, 2003 Closing Date: December 31, 2012

Chair: (Italy) Prof. Massimo Federico, Gruppo Italiano Studio Linfomi (GISL), (59) 422-4383, (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Closed to Accrual
LY15A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma.
A Phase I Study of Romidepsin, Gemcitabine, Dexamethasone and Cisplatin Combination Therapy in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma.

Complexity Level: 2

Eligibility: Patients enrolled in this study must have histologically confirmed peripheral T cell lymphoma (PTCL) or diffuse large B cell lymphoma, and must have received one or two previous treatment regimens (histologic proof of disease by biopsy is mandatory). There must be clinically or radiologically measurable disease at baseline.

Objectives: - To evaluate the safety and feasibility of the combination of gemcitabine, dexamethasone and cisplatin (GDP) and romidepsin in relapsed/refractory aggressive lymphomas (including PTCL and DLBCL). - To identify the maximum tolerated doses of romidepsin, gemcitabine, dexamethasone and cisplatin used in combination. - To evaluate preliminary evidence of anti-tumour activity. - To establish a recommended phase II dose of romidepsin to be given in combination with GDP in a planned randomized phase II trial in newly diagnosed untreated PTCL.

NCT Registration ID (from clinicaltrials.gov): NCT01846390
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: April 30, 2013 Closing Date: April 26, 2016

Chair: (Canada) Dr. Anthony J. Reiman, Atlantic Health Sciences Corporation, (506) 648-6884, (Canada) Dr. Kerry J. Savage, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2641


Closed to Accrual
LY16 (LYSARC RELEVANCE)A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma
A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma

Complexity Level: 2

Eligibility: Investigator-assessed diagnosis of Stage II-IV CD20+ follicular lymphoma (grade 1-3a)

Objectives: Co-Primary: complete response (CR/CRu), progression free survival (PFS) Secondary: event free survival (EFS),time to next anti-lymphoma treatment (TTNLT, overall survival (OS), safety, Exploratory: CR rate at 120 weeks and PFS, time to treatment failure (TTF), time to next chemotherapy treatment (TTNCT) and overall response rate (ORR) at 120 weeks, biomarker analysis, health related QoL and health economics.

NCT Registration ID (from clinicaltrials.gov): NCT01650701
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: June 17, 2013 Closing Date: November 10, 2014

Chair: (Canada) Dr. Laurie Sehn, BCCA - Vancouver Clinic, (604) 877-6000 Ext. 2736


Closed to Accrual
LYC1 (ECOG E1411)Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB -> R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV -> R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB -> LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV -> LR)
Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB -> R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV -> R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB -> LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV -> LR)

Complexity Level: 2

Eligibility: Patients must have confirmed diagnosis of mantle cell lymphoma and must be greater than 18 years old.

Objectives: Primary: progression free survival in induction and consolidation Secondary: PET document complete response rate, objective response rate, overall survival, safety

NCT Registration ID (from clinicaltrials.gov): NCT01415752
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: March 12, 2014 Closing Date: September 09, 2016

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Closed to Accrual
MDC1 (SWOG S1117)A Randomized Phase II/III Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)
A Randomized Phase II/III Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Complexity Level: 2

Eligibility: Patients must have morphologically confirmed diagnosis of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML).

Objectives: Primary: Response Rate Secondary: Relapse-free Survival; Overall Survival; Cytogenetic Response Rate; Frequency and Severity of Toxicities; Predictors of Response; Optional Tumour Banking

NCT Registration ID (from clinicaltrials.gov): NCT01522976
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: November 22, 2012 Closing Date: November 15, 2014

Chair: (Canada) Dr. Rena Buckstein, Odette Cancer Centre, (416) 480-5000 Ext. 5847


Closed to Accrual
AL1Reinduction and Maintenance of Second or Third Remissions in Children With Acute Lymphoblastic and Acute Undifferentiated Leukemia
Reinduction and Maintenance of Second or Third Remissions in Children With Acute Lymphoblastic and Acute Undifferentiated Leukemia

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 07, 1981 Closing Date: June 08, 1982

Permanently Closed
AL2 (INT 0129)Phase III Randomized Study of All-Trans Retinoic Acid versus Cytosine Arabinoside and Daunorubicin as Inductive Therapy for Patients with Previously Untreated Acute Promyelocytic Leukemia
Phase III Randomized Study of All-Trans Retinoic Acid versus Cytosine Arabinoside and Daunorubicin as Inductive Therapy for Patients with Previously Untreated Acute Promyelocytic Leukemia

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: August 01, 1992 Closing Date: February 01, 1995

Permanently Closed
AL3 (CALGB C9710)Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy with Intermittent Tretinoin vs Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients with Untreated Acute Promyelocytic Leukemia
Phase III Randomized Study of Concurrent Tretinoin and Chemotherapy With or Without Arsenic Trioxide (AS2O3) (NSC # 706363) as Initial Consolidation Therapy Followed by Maintenance Therapy with Intermittent Tretinoin vs Intermittent Tretinoin Plus Mercaptopurine and Methotrexate for Patients with Untreated Acute Promyelocytic Leukemia

Complexity Level: 1

Eligibility: Diagnosis of acute promyelocytic leukemia (APL) with proof of APL morphology (FAB-M3) confirmed by RT-PCR assay. Prior treatment: No systemic definitive treatment for APL, including cytotoxic chemotherapy or retinoids. Prior therapy with corticosteroids, hydroxyurea or leukapheresis will not exclude the patient. Non-pregnant, non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Patients should not become pregnant or plan to become pregnant while on treatment.

Objectives: To compare the efficacy (event-free survival) and toxicities of two induction/consolidation therapies for patients with untreated APL: ATRA/ara-C/daunorubicin with or without arsenic trioxide (AS2O3). To evaluate the efficacy (disease-free survival) and toxicities of maintenance therapy with intermittent ATRA versus intermittent ATRA plus 6-MP/MTX for patients with APL who achieve a complete response.

NCT Registration ID (from clinicaltrials.gov): NCT00003934
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: April 18, 2002 Closing Date: March 29, 2005

Chair: (Canada) Dr. Stephen Couban, QEII Health Sciences Centre, (902) 473-8562


Permanently Closed
AL4 (DFCI 01-175)A Multi-Center Phase II Study in Adults with Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol
A Multi-Center Phase II Study in Adults with Untreated Acute Lymphoblastic Leukemia: Testing Pharmacokinetically Individualized Doses of L-Asparaginase Following the DFCI Pediatric Consortium Protocol

Complexity Level: 1

Eligibility: Patients must have pathologically documented de novo acute lymphoblastc leukemia, excluding mature B-cell ALL, which is diagnosed by the presence of either surface immunoglogulin, L3 morphology or one of the following cytogentic abnormalities t(8;14)(q24;q32), t(8;22), or t(2;8).

Objectives: To determine the feasibility, toxicity and efficacy of the high-risk pediatric treatment regimen in adult patients 18 years of age and older. To determine the safety and optimal dosing of L-asparaginase during the intensification period. To determine the pharmacokinetics of weekly E.coli L-asparaginase by evaluating serum asparaginase levels in all patients To determine the toxicity of individualized dosing of E.coli L-asparaginase based upon asparaginase levels To determine the prognostic significance of early response to induction chemotherapy within the context of our treatment program To evaluate the outcome of patients based upon bone marrow status after 15 days of multi-agent induction chemotherapy, comparing the outcome of patients with M3 status (>25% leukemia cells still present) at that time point versus those with M1/M2 status (<25% leukemia cells still present) or hypoplastic marrows. To evaluate the outcome of patients base

NCT Registration ID (from clinicaltrials.gov): NCT00136435
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: January 24, 2005 Closing Date: February 21, 2008

Chair: (Canada) Dr. Stephen Couban, QEII Health Sciences Centre, (902) 473-8562


Permanently Closed
ALC1 (S0106)A Phase III Study Of The Addition Of Mylotarg? During Induction Therapy Verses Standard Induction With Daunomycin & Cytosine Arabinoside Followed By Consolidation & Subsequent Randomization To Post-Consolidation Therapy With Mylotarg? Or No Additional Therapy For Patients Under The Age Of 61 With Previously Untreated De Novo Acute Myeloid Leukemia
A Phase III Study Of The Addition Of Mylotarg? During Induction Therapy Verses Standard Induction With Daunomycin & Cytosine Arabinoside Followed By Consolidation & Subsequent Randomization To Post-Consolidation Therapy With Mylotarg? Or No Additional Therapy For Patients Under The Age Of 61 With Previously Untreated De Novo Acute Myeloid Leukemia

Complexity Level: 1

Eligibility: Patients must have a morphologically confirmed diagnosis of acute myeloid leukemia (AML) with FAB classification other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration.

Objectives: -Compare DFS of patients under age 56 with previously untreated, de novo, non-M3, AML who receive Mylotarg as post-consolidation therapy versus patients who receive no post-consolidation therapy. -Compare CR rate achieved by the addition of Mylotarg to standard induction chemotherapy in patients under the age of 56 with previously untreated, de novo, non-M3 AML. The durability of complete response will also be measured. -Estimate the frequency and severity of toxicities of the addition of Mylotarg to induction therapy and post-consolidation therapy. -To evaluate the prognostic significance of CD33 expression on the response rate of patients who receive Mylotarg. -To evaluate the prognostic significance of FLT3 mutations and flow through cytometic detection prior to therapy, and of minimal residual disease in remission specimens collected before and after consolidation therapy and after post-consolidation therapy with Mylotarg.

NCT Registration ID (from clinicaltrials.gov): NCT00085709
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: April 27, 2006 Closing Date: August 20, 2009

Chair: (Canada) Dr. Thomas J. Nevill, Vancouver General Hospital, (604) 875-4863


Permanently Closed
CL1 (9011)A Phase III Comparison of Fludarabine Phosphate (NSC #312887) vs Chlorambucil vs Fludarabine Phosphate + Chlorambucil in Previously Untreated B-Cell Chronic Lymphocytic Leukemia
A Phase III Comparison of Fludarabine Phosphate (NSC #312887) vs Chlorambucil vs Fludarabine Phosphate + Chlorambucil in Previously Untreated B-Cell Chronic Lymphocytic Leukemia

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: March 08, 1991 Closing Date: December 07, 1994

Chair: (USA) Dr. Jonathan Kolitz, North Shore University Hospital - Manhasset, (631) 562-8970, (USA) Dr. Kanti Rai, Long Island Jewish Medical Centre, (718) 470-7135


Permanently Closed
CL2A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia
A Phase II Study of Oral Fludarabine Phosphate in Patients with Previously Untreated B-cell Chronic Lymphocytic Leukemia

Eligibility: Patients with previously untreated B-cell chronic lymphocytic leukemia, requiring treatment. Submission of blood samples for immunophenotyping, FISH and PCR studies are a requirement for participation.

Objectives: To determine overall (CR, PR) response rate. Secondary endpoints include assessment of molecular CR rate, toxicity, progression-free and treatment-free survival as well as determination of the incidence of defined genetic abnormalities in the study population. The prognostic and predictive significance of genetic abnormalities and immunophenotypic profile at the start of treatment, with respect to response to oral fludarabine, will be evaluated.

NCT Registration ID (from clinicaltrials.gov): NCT00049075
Participation: Limited to centres expecting to accrue > 4 patients/year
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 08, 2002 Closing Date: January 30, 2004

Permanently Closed
CLC1E (CLC1E)A Canadian Economic Analysis of CLC.1
A Canadian Economic Analysis of CLC.1

Complexity Level: 3

Eligibility: Tumour Type: CLL Line of Therapy: 1st line therapy Stage of Disease: Previously untreated, early-stage patients who are candidates for observation. Only patients ncluded in the randomized portion of this trial (those with the poor-risk molecular marker) will be included in the Economic Analysis.

Objectives: Primary: Time to 2nd treatment; The primary outcome of the economic analysis is cost-utility. Utilities will be determined through use of the Euro QoL Eq5D questionnaire. Data to be obtained from Canadian patients includes health care-related resource utilization and lost productivity. Secondary: Overall survival; toxicity; correlative markers; QoL. Secondary outcomes of economic analysis: cost effectiveness related to 'years gained' prior to second therapy and if possible 'years gained'. Lost productivity of the two randomized groups will also be compared.

NCT Registration ID (from clinicaltrials.gov): NA
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 13, 2009 Closing Date: December 24, 2009

Chair: (Canada) Dr. Matthew Cheung, Odette Cancer Centre, (416) 480-5000 Ext. 4757


Permanently Closed
CM1 (SWOG S0325)A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib (BMS 354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase.
A Phase IIb Study of Molecular Responses to Imatinib at Standard or Increased Doses or Dasatinib (BMS 354825) (NSC-732517) for Previously Untreated Patients with Chronic Myelogenous Leukemia (CML) in Chronic Phase.

Complexity Level: 2

Eligibility: Patients with chronic phase CML are eligible based on bone marrow aspirate, biopsy and peripheral blood counts obtained within 14 days before registration. Patients must have confirmed Philadelphia chromosome or variants of the (9-22) translation by cytogenetics or by FISH or be positive for BCR-ABL by RT-PCR. Patients may have secondary chromosomal abnormalities in addition to the Philadelphia chromosomes. Patients must have a Zubroid performance status of 0 - 2. Patients must not have received prior treatment for CML with the exception of hydroxyurea and/or anagrelide. Patients must not have received prior chemotherapy for peripheral blood stem cell mobilization.

Objectives: 1.1 To test whether increasing the dose of imatinib (STI571, Gleevec?) from 400 mg/day to 800 mg/day increases the rate of molecular response, as measured by the decrease in BCR-ABL transcripts after 12 months of treatment, in patients with previously untreated CML in chronic phase. 1.2 To estimate rates of cytogenetic and hematologic responses to each of the two imatinib dose levels. 1.3 To evaluate in a preliminary manner the prognostic effects of der(9) and der(22) chromosomal deletions for response in CML patients treated with imatinib. 1.4 To investigate in a preliminary manner changes in gene expression at relapse or progression compared to pre-treatment. 1.5 To estimate the frequency and severity of toxicities of the two treatment regimens.

NCT Registration ID (from clinicaltrials.gov): NCT00070499
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: September 30, 2005 Closing Date: February 28, 2009

Chair: (Canada) Dr. Jeffrey H. Lipton, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 2268


Permanently Closed
HD1Protocol For a Cooperative Clinical Trial Comparing MOPP Alone versus MOPP Followed by Radiation in Stage IIIB and IV Hodgkin's Disease
Protocol For a Cooperative Clinical Trial Comparing MOPP Alone versus MOPP Followed by Radiation in Stage IIIB and IV Hodgkin's Disease

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 01, 1971 Closing Date: September 01, 1976

Permanently Closed
HD2Comparison of Radiotherapy Alone With Radiotherapy Preceded by or Preceded and Followed by Three Courses of MOPP, With Standardized Treatment of First and Second Relapse and Incomplete Remission
Comparison of Radiotherapy Alone With Radiotherapy Preceded by or Preceded and Followed by Three Courses of MOPP, With Standardized Treatment of First and Second Relapse and Incomplete Remission

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 14, 1977 Closing Date: June 11, 1979

Permanently Closed
HD3Protocol For a Second Cooperative Clinical Trial for the Treatment of Patients With Stages IVB and IV Hodgkin's Disease Using Chemotherapy and Irradiation Therapy
Protocol For a Second Cooperative Clinical Trial for the Treatment of Patients With Stages IVB and IV Hodgkin's Disease Using Chemotherapy and Irradiation Therapy

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 01, 1977 Closing Date: May 01, 1980

Permanently Closed
HD4A Clinical Trial of MOPP/ABV Hybrid versus Alternating MOPP/ABVD for Advanced or Recurrent Hodgkin's Disease
A Clinical Trial of MOPP/ABV Hybrid versus Alternating MOPP/ABVD for Advanced or Recurrent Hodgkin's Disease

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 15, 1984 Closing Date: December 29, 1989

Chair: (Canada) Dr. Joseph M. Connors, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
HD5 (8952)Treatment of Advanced Hodgkin's Disease a Randomized Phase III Trial Comparing ABVD versus MOPP/ABV Hybrid
Treatment of Advanced Hodgkin's Disease a Randomized Phase III Trial Comparing ABVD versus MOPP/ABV Hybrid

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 01, 1993 Closing Date: November 10, 1995

Chair: (Canada) Dr. Joseph M. Connors, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
HD6A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease
A Phase III Study of Radiotherapy or ABVD Plus Radiotherapy versus ABVD Alone in the Treatment of Early Stage Hodgkin's Disease

Eligibility: Patients with clinical stage I or IIA previously untreated Hodgkin's disease, excluding patients with very favourable or very unfavourable (bulky mediastinum) prognosis.

Objectives: To compare 12 year survival between groups, to assess freedom from progression at 5 and 10 years, and to assess secondary endpoints: proportion of complete remission, proportion free from 2nd disease progression at 5 and 10 years, cause specific survival, toxicity, and quality of life.

NCT Registration ID (from clinicaltrials.gov): NCT00002561
Participation: Limited to centres with current CPA #
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 25, 1994 Closing Date: April 05, 2002

Permanently Closed
HD7 (ECOG E2496)A Randomized Phase III Trial of ABVD Versus Stanford V with or without Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease
A Randomized Phase III Trial of ABVD Versus Stanford V with or without Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease

Complexity Level: 2

Eligibility: Previously untreated patients with histologically proven Hodgkin's disease (HD). The diagnosis should be made by excisional biopsy whenever possible, but fine needle aspirate may suffice if 1) the morphology is unequivocal and 2) immunohistochemical studies are consistent with the diagnosis of HD. ECOG performance status must be 0 - 2.

Objectives: To compare the failure-free survival in patients with locally extensive and advanced stage Hodgkin's disease treated with standard ABVD chemotherapy versus patients given Stanford V chemotherapy with or without radiotherapy. To assess overall survival and freedom from progression in these patients at 5 and 10 years. To assess secondary endpoints: pulmonary function, incidence of second cancers, reproductive function (baseline and 5 years) and deaths from causes other than Hodgkin's disease.

NCT Registration ID (from clinicaltrials.gov): NCT00003389
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: June 07, 2000 Closing Date: June 15, 2006

Chair: (Canada) Dr. Joseph M. Connors, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
HL1 (8691)A Randomized Comparison of Deoxycoformycin versus Alpha Interferon in Previously Untreated Patients With Hairy Cell Leukemia
A Randomized Comparison of Deoxycoformycin versus Alpha Interferon in Previously Untreated Patients With Hairy Cell Leukemia

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: January 05, 1987 Closing Date: October 01, 1991

Permanently Closed
I100NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML
NCIC CTG Phase II Combination Trial of Topotecan and Etoposide in Patients with AML

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 09, 1996 Closing Date: May 13, 1998

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
I108A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma
A Phase II Study of Topotecan and Etoposide in Patients With Intermediate Grade Non-Hodgkin's Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 05, 1997 Closing Date: May 07, 1998

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
I127A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
A Phase II Study of Flavopiridol (HMR 1275; NSC 649890) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

Eligibility: Histologically or cytologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or with no prior therapy. Pathology must be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility BEFORE patient registration if questionable. Presence of clinically and/or radiologically documented disease. 0-2 prior chemotherapy regimens permitted. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

Objectives: To assess the efficacy of flavopiridol, given as a 3 day bolus every 21 days. To assess the toxicity of flavopiridol when administered on this schedule in the patient group.

NCT Registration ID (from clinicaltrials.gov): NCT00005074
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 24, 2000 Closing Date: October 10, 2001

Chair: (Canada) Dr. Joseph M. Connors, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I141A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
A Randomized Phase I Study of Two Different Schedules of BAY 43-9006 in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Eligibility: Acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), not requiring urgent cytoreductive therapy. One prior chemotherapy regimen permitted.

Objectives: To determine the maximum tolerated doses (MTD) and the recommended doses (RD) of two different schedules of BAY 43-9006 in patients with AML or MDS. To determine toxic effects, pharmacokinetics, gene expression, target effects and clinical response rates of BAY-43-9006 in this patient population.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 01, 2001 Closing Date: April 01, 2004

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
I145A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma
A Phase II Study of ZD6474 in Patients With Relapsed Multiple Myeloma

Eligibility: Patients with confirmed diagnosis of multiple myeloma with a measurable serum or urine M-component at initial diagnosis. Patients must have relapsed following first or second line oral alkylating therapy or high dose chemotherapy and stem cell transplant. Patients are not eligible if they relapsed during prior treatment, have had > 2 prior chemotherapy regimens or relapsed within 3 months after last treatment.

Objectives: To assess the efficacy of ZD6474 when given orally to patients with relapsed previously treated multiple myeloma. To determine the toxic effects, duration of response, time to progression, and pharmacokinetics profile and characteristics, as well as to examine bone marrow samples in patients with multiple myeloma given ZD6474.

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 02, 2002 Closing Date: April 08, 2004

Chair: (Canada) Dr. Michael J. Kovacs, London Health Sciences Centre, (519) 685-8500 Ext. 52254


Permanently Closed
I150A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma
A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Mantle Cell Lymphoma

Eligibility: Histologically documented mantle cell lymphoma (at initial diagnosis) non-refractory to prior therapy or no prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. O-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior investigational therapy. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To determine 20S proteasome levels in whole blood and correlate suppression of this marker with toxicity and response to PS-341.

NCT Registration ID (from clinicaltrials.gov): NCT00030875
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 04, 2002 Closing Date: July 28, 2004

Chair: (Canada) Dr. Andrew Belch, Cross Cancer Institute, (780) 432-8757


Permanently Closed
I152 (IND.152)A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia
A Phase II Study of PS-341 (NSC 681239) in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia

Eligibility: Confirmed diagnosis of Waldenstrom's Macroglobulinemia. If newly diagnosed or untreated must have IgM > 20 g/L, if previously treated IgM must be > 5g/L at time of registration. Must be symptomatic. O-2 prior chemotherapy regimens, non-refractory to prior therapy; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant. Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted.

Objectives: To assess efficacy of PS-341 given as a bolus IV injection twice weekly for two out of three weeks. To assess the toxicity of PS-341 when administered on this schedule in this patient group. To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray.

NCT Registration ID (from clinicaltrials.gov): NCT00045695
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 27, 2002 Closing Date: March 23, 2005

Chair: (Canada) Dr. Christine Chen, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2827


Permanently Closed
I16NCIC CTG Phase II Study of Acivicin in Lymphoma
NCIC CTG Phase II Study of Acivicin in Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 12, 1984 Closing Date: October 30, 1987

Permanently Closed
I172Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.
Phase II Study Of Bortezomib And Gemcitabine In Patients With Relapsed Mantle Cell Lymphoma.

Eligibility: Histologically documented mantle cell lymphoma non-refractory to prior therapy. Pathology will be reviewed by the Central Reference Pathologist at BCCA to confirm eligibility. Bidimensionally measurabe disease. 1-2 prior chemotherapy regimens; not permitted: radioactive MoAb therapy, high dose chemotherapy with stem cell transplant or prior PS-341/bortezomib or other investigational therapy (excluding flavopiridol). Prior radiation permitted if < 25% functioning bone marrow; prior surgery permitted. Adequate organ function; no pre-existing edema, neuropathy or dyspnea >= gr 2 or ascites or pleural effusions. No serious cardiovascular disease and adequate cardiac function - LVEF >= 45%.

Objectives: To determine the efficacy (response rate) of bortezomib given as a bolus intravenous injection twice weekly for 2 out of 3 weeks in combination with gemcitabine given as a 30 min. intravenous infusion once weekly for two consecutive weeks in patients with relapsed mantle cell lymphoma. To assess the toxicity of this combination as well as time to progression and response duration.

NCT Registration ID (from clinicaltrials.gov): NCT00377052
Participation: Limited to selected centres.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 14, 2006 Closing Date: September 19, 2008

Chair: (Canada) Dr. Tom Kouroukis, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 62487


Permanently Closed
I182A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma
A Phase II Study Of Sunitinib (SU11248; NSC 736511; IND 74019), An Oral Multi-Targeted Tyrosine Kinase Inhibitor, In Patients With Relapsed Or Refractory Diffuse Large B-Cell Lymphoma

Eligibility: - Histologically documented diffuse large B-cell or mediastinal (thymic) large B-cell lymphoma, advanced or metastatic disease. - Patients must have received at least one, and up to two prior chemotherapy regimens, one of which must have been doxorubicin-based. - Patients may be relapsed post stem cell transplant as the preparative regimen and high dose chemotherapy will be considered as one regimen. Patients may have received one other non-chemotherapy regimen in the form of radiation. - No prior therapy with angiogenesis inhibitors or multi-targeted tyrosine kinase inhibitors - > 28 days since prior chemotherapy, hormonal therapy, radiation therapy or major surgery - Bidimensionally measurable disease; no known brain metastases - ECOG performance status: 0 or 1 - No serious medical conditions or cardiac disease (as specified in protocol); no uncontrolled hypertension

Objectives: 1. To assess the efficacy (response rate) of sunitinib given orally daily in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 2. To assess the toxicity of sunitinib in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma. 3. To assess the effects of sunitinib on the peripheral blood biomarkers circulating endothelial cells (CECs) and their precursors (CEPs) in patients with relapsed or refractory diffuse or thymic (mediastinal) large B-cell lymphoma.

NCT Registration ID (from clinicaltrials.gov): NCT00392496
Participation: Limited to invited centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 08, 2006 Closing Date: March 24, 2009

Chair: (Canada) Dr. Rena Buckstein, Odette Cancer Centre, (416) 480-5000 Ext. 5847


Permanently Closed
I186A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS
A Phase I/II Study of Sorafenib (BAY 43-9006) In Combination With Low Dose ARA-C (Cytarabine) In Elderly Patients With AML Or High-Risk MDS

Complexity Level: 1

Eligibility: Patients age > 60 years and not suitable for intensive chemotherapy regimens with pathologically confirmed AML or high-risk MDS. o ECOG performance status 0, 1, or 2 o Prior Chemotherapy: None except hydroxyurea permitted provided discontinued > 48 hours prior to start of protocol therapy o Biochemistry: bilirubin and creatinine within normal limits, AST/ALT < 2 x UNL o No documented CNS involvement o No serious medical condition including: significant neurologic or psychiatric disorder, active uncontrolled infection

Objectives: Phase I Portion: To determine the recommended dose of sorafenib and Ara-C given in combination in elderly patients with AML or high-risk MDS who are not suitable for intensive chemotherapy. To determine the safety, tolerability, toxicity profile and dose limiting toxicities of the combination sorafenib and Ara-C in this patient population. Phase II Portion: To estimate the efficacy (as measured by complete response rate) of the recommended dose of sorafenib given orally in combination with Ara-C in elderly patients with AML or high-risk MDS. To describe the toxic effects and overall response rate (complete plus partial) in this population. To evaluate potential correlates of response in translational research studies including FLT-3 ITD's and point mutations in blasts.

NCT Registration ID (from clinicaltrials.gov): NCT00516828
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 24, 2007 Closing Date: December 10, 2009

Chair: (Canada) Dr. Brian Leber, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 575-7820, (Canada) Dr. David A. Macdonald, Ottawa Hospital Research Institute


Permanently Closed
I191A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma
A Phase II Study of AT9283 in Patients with Relapsed or Refractory Multiple Myeloma

Complexity Level: 2

Eligibility: Patients must have a confirmed diagnosis of multiple myeloma and measurable disease, according to internationally accepted criteria for myeloma. Patients must have received prior treatment for multiple myeloma, and have relapsed or progressed on prior therapy. No more than three prior regimens; prior treatment must be completed at least 4 weeks prior to registration. ECOG performance status must be 0, 1 or 2; adequate hematologic and organ function.

Objectives: To assess the efficacy of AT9283 when given as a 24 hour infusion on Days 1 and 8 every three weeks to patients with relapsed or refractory multiple myeloma; to determine the adverse effects of AT9283; to evaluate potential predictive and prognostic biomarkers (marrow, blood); and to evaluate disease-related symptoms including pain, fatigue and mucositis.

NCT Registration ID (from clinicaltrials.gov): NCT01145989
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 15, 2010 Closing Date: July 26, 2012

Chair: (Canada) Dr. Anthony J. Reiman, Atlantic Health Sciences Corporation, (506) 648-6884


Permanently Closed
I193A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.
A Phase II Study of AT7519M, A CDK Inhibitor in Patients with Relapsed and/or Refractory Chronic Lymphocytic Leukemia.

Complexity Level: 2

Eligibility: Patients with documented chronic lymphocytic leukemia with at least one and up to 3 prior systemic treatment regimens. Patients must have either lymphocyte count >= 10 x 109/L or at least one measurable lymph node >= 2 cm x 2 cm to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.

Objectives: To assess the efficacy of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed and/or refractory chronic lymphocytic leukemia. To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed/refractory CLL. To demonstrate the pharmacodynamic activity of AT7519M in patients with relapsed and/or refractory CLL by establishing its effects on relevant biological endpoints (markers of CDK inhibition, apoptotic markers and cell cycle suppressors) in circulating lymphocytes. To investigate the relationship between baseline cytogenetics and other molecular markers in response to AT7519M.

NCT Registration ID (from clinicaltrials.gov): NCT01627054
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 21, 2012 Closing Date: November 22, 2013

Permanently Closed
I194A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma
A Phase II Study of AT7519M, a CDK Inhibitor, in Patients with Relapsed Mantle Cell Lymphoma

Complexity Level: 2

Eligibility: Patients with documented mantle cell lymphoma non-refractory to prior therapy. Patients must have received at least one and up to 3 prior systemic treatment regimens. Patients must have at least one site of bidimensional disease to be eligible. No pre-existing cardiovascular conditions or symptomatic cardiac dysfunction. Acceptable end-organ function. ECOG 0, 1 or 2.

Objectives: Primary: To assess the efficacy (as assessed by objective response rate) of AT7519M when given as a 1 hour intravenous infusion twice weekly for two out of three weeks in patients with relapsed mantle cell lymphoma (MCL). Secondary: - To assess the toxicity, time to progression and response duration of AT7519M in patients with relapsed mantle cell lymphoma. - To explore potential proteomic and metabolic serum markers of clinical response to AT7519M in MCL by assessment of peripheral blood collected at baseline and on study.

NCT Registration ID (from clinicaltrials.gov): NCT01652144
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 24, 2012 Closing Date: May 07, 2014

Chair: (Canada) Dr. John Kuruvilla, University Health Network, (416) 946-2827


Permanently Closed
I20NCIC CTG Phase II Study of Menogaril in Lymphoma
NCIC CTG Phase II Study of Menogaril in Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 30, 1985 Closing Date: November 14, 1988

Permanently Closed
I22NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell
NCIC CTG Phase II Study of Deoxycoformycin in Hairy Cell

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 26, 1985 Closing Date: July 15, 1986

Permanently Closed
I3NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma
NCIC CTG Phase II Study of Spirogermanium in Poor Prognosis Non-Hodgkin's Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 09, 1983 Closing Date: May 14, 1984

Permanently Closed
I62NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma
NCIC CTG Phase II Study of Subcutaneous R-Interleukin-2 Plus Interferon Alfa-2a in Previously Treated Patients With Multiple Myeloma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 07, 1991 Closing Date: February 17, 1993

Permanently Closed
I78NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma
NCIC CTG Phase II Study of Didemnin-B in Previously Untreated Patients With Favourable Histology Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 01, 1993 Closing Date: October 25, 1994

Chair: (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955


Permanently Closed
I84NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia
NCIC CTG Phase I Study of Topotecan and Etoposide in Patients With Refractory or Relapsed Acute Leukemia

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 07, 1994 Closing Date: November 23, 1995

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
LY1A Trial of BCG in Non-Hogkin's Lymphoma
A Trial of BCG in Non-Hogkin's Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 07, 1976 Closing Date: May 01, 1981

Permanently Closed
LY10A Phase II Study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) in Patients With Either Hodgkin's Disease or Aggressive Histology Non-Hodgkin's Lymphoma Which is Relapsed or Refractory
A Phase II Study of Gemcitabine, Dexamethasone, and Cisplatin (GDP) in Patients With Either Hodgkin's Disease or Aggressive Histology Non-Hodgkin's Lymphoma Which is Relapsed or Refractory

Eligibility: Patients with a diagnosis of either Hodgkin's disease or aggressive histology non-Hodgkin's lymphoma of B-cell origin, whose disease is refractory to or relapsed after one prior chemotherapy regimen.

Objectives: To determine the efficacy (response rates and percent of complete remissions) following two cycles of treatment with GDP for patients with relapsed or refractory Hodgkin's disease and for patients with relapsed or refractory aggressive histology non-Hodgkin's lymphoma

NCT Registration ID (from clinicaltrials.gov): NCT00014209
Participation: Not limited.
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 12, 2000 Closing Date: July 12, 2002

Chair: (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
LY11 (S9704)A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups
A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups

Complexity Level: 1

Eligibility: Patients must have biopsy proven intermediate or high grade non-Hodgkin's lymphoma (Working Formulation groups D through H and J) except lymphoblastic lymphoma (Working Formulation group I). Transformed lymphomas are not eligible. Mantle cell lymphomas are considered to be Working Formulation group E, but are ineligible for this study.

Objectives: To compare in a cooperative group setting the overall survival and progression free survival of patients in the age adjusted High-Intermediate and High Risk Prognostic Groups of the International Classification with diffuse aggressive non-Hodgkin?s lymphomas who are treated on a randomized trial that compares standard conventional chemotherapy to an abbreviated course of induction chemotherapy followed by early transplantation. To compare the toxicity of these treatment strategies.

NCT Registration ID (from clinicaltrials.gov): NCT00004031
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: November 28, 2001 Closing Date: December 15, 2007

Chair: (Canada) Dr. Stephen Couban, QEII Health Sciences Centre, (902) 473-8562


Permanently Closed
LY13A Multi-centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone and Rituximab (BCVP-R) for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment
A Multi-centre Phase II Trial Investigating the Efficacy and Tolerability of Bortezomib Added to Cyclophosphamide, Vincristine, Prednisone and Rituximab (BCVP-R) for Patients with Advanced Stage Follicular Non-Hodgkin's Lymphoma Requiring Systemic First-Line Treatment

Eligibility: Patients with histologically confirmed, advanced stage (III or IV) follicular lymphoma requiring systemic first-line treatment will be eligible.

Objectives: Primary: To assess the efficacy (complete response rate, CR/CRu) of BCVP-R as treatment for patients with advanced stage follicular non-Hodgkin's lymphoma requiring systemic first-line treatment; to assess the incidence of severe neurotoxicity (defined as grade 3 or 4 neuropathy/ neuropathic pain during the first four cycles) of the BCVP-R regimen in this group of patients. Secondary: To assess overall response rate in patients treated with the combination of BCVP-R, and to determine the response duration; to determine progression-free and overall survival in this patient group; to evaluate the tolerability and characterize the toxicity profile of the BCVP-R regimen in this patient population; to assess quality of life with particular focus on neurotoxicity-related changes in this patient population treated with BCVP-R. Correlative Studies. Apoptocic molecule expression, the role of the microenvironment, and Fc receptor polymorphisms.

NCT Registration ID (from clinicaltrials.gov): NCT00428142
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 14, 2006 Closing Date: March 06, 2009

Chair: (Canada) Dr. Laurie Sehn, BCCA - Vancouver Clinic, (604) 877-6000 Ext. 2736, (Canada) Dr. Michael Crump, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4567


Permanently Closed
LY2Treatment of Poor Prognosis Lymphomas With Bone Marrow Involvement, Intensive BACOP Chemotherapy Under Cover of Septra Prophylaxis
Treatment of Poor Prognosis Lymphomas With Bone Marrow Involvement, Intensive BACOP Chemotherapy Under Cover of Septra Prophylaxis

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 01, 1980 Closing Date: December 01, 1980

Permanently Closed
LY3A Comparison of Standard BACOP With Escalated BACOP in Patients With Poor Prognosis Non-Hodgkin's Lymphoma
A Comparison of Standard BACOP With Escalated BACOP in Patients With Poor Prognosis Non-Hodgkin's Lymphoma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 10, 1982 Closing Date: April 19, 1989

Permanently Closed
LY4Phase I/II Study of Chemotherapy Intensification for Patients With Poor Prognosis Advanced Stage Aggressive histology Lymphoma: VACOP-B Plus Etoposide and Cyclophosphamide With RhuGM-CSF (VACOP-B/EC/CSF)
Phase I/II Study of Chemotherapy Intensification for Patients With Poor Prognosis Advanced Stage Aggressive histology Lymphoma: VACOP-B Plus Etoposide and Cyclophosphamide With RhuGM-CSF (VACOP-B/EC/CSF)

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 1992 Closing Date: October 25, 1994

Chair: (Canada) Dr. Joseph M. Connors, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
LY7 (EORTC 20981)Chimeric Anti-CD20 Monoclonal Antibody (Rituximab)in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma: A Phase III Randomized Clinical Trial
Chimeric Anti-CD20 Monoclonal Antibody (Rituximab)in Remission Induction and Maintenance Treatment of Relapsed Follicular Non-Hodgkins Lymphoma: A Phase III Randomized Clinical Trial

Complexity Level: 2

Eligibility: Patients with stage III or IV follicular non-Hodgkin's lymphoma (at initial diagnosis) who have relapsed after a maximum of two non-anthracycline containing systemic chemotherapy regimens. Patients must have had a complete or partial response to at least one of the previous regimens. Lymphoma must be CD20 positive.

Objectives: To establish the effect of addition of rituximab to CHOP chemotherapy on the response rate and quality of remission in relapsed low grade non-Hodgkin's lymphoma. To establish the effect of maintenance treatment with rituximab on progression free survival in relapsed low grade non-Hodgkin's lymphoma in remission after CHOP ? rituximab.

NCT Registration ID (from clinicaltrials.gov): NCT00004179
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: May 15, 2000 Closing Date: February 06, 2004

Permanently Closed
LY9 (M39045)Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8)
Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkins Lymphoma With a CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8)

Complexity Level: 2

Eligibility: Patients aged 18 to 60 years with untreated CD20-positive diffuse large B-cell non-Hodgkin's lymphoma. Patients must have stage II to IV or stage I with bulky disease according to Ann Arbor staging.

Objectives: To determine the safety and efficacy of rituximab antibody in patients with diffuse large B-cell non-Hodgkin's lymphoma in combination with a standard CHOP-like chemotherapy regimen. The primary endpoint of this trial is the time to treatment failure.

NCT Registration ID (from clinicaltrials.gov): NCT00064116
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: May 08, 2001 Closing Date: October 17, 2003

Chair: (Canada) Dr. Kevin R. Imrie, Odette Cancer Centre, (416) 480-5000 Ext. 5145


Permanently Closed
MY1A Comparison of the Administration of Melphalan, Cyclophosphamide and BCNU in Sequential Alternating and Concurrent Schedules in the Treatment of Plasma Cell Myeloma
A Comparison of the Administration of Melphalan, Cyclophosphamide and BCNU in Sequential Alternating and Concurrent Schedules in the Treatment of Plasma Cell Myeloma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 01, 1973 Closing Date: March 01, 1977

Permanently Closed
MY10 (MY10)A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma
A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma

Complexity Level: 2

Eligibility: Patients with histologically confirmed myeloma who had had an autologous stem cell transplant within one year of the beginning of initial treatment for their disease. Patients must be randomized within 60-100 days post transplant and have no other medical condition precluding long term use of prednisone or thalidomide.

Objectives: Primary: to determine if maintenance treatment post transplant with thalidomide and prednisone (TP) prolongs overall survival compared with observation alone. Secondary: to determine if TP prolongs progression-free survival compared with observation alone; to compare quality of life, toxic effects, and the incidence of venous thromboembolism between the two patient groups. Correlative Studies Endpoints: to correlate FISH-identified chromosome translocations at relapse with clinical outcome in the two patient groups; to determine if there is evidence of increased thrombin generation in patients receiving TP as compared with those not.

NCT Registration ID (from clinicaltrials.gov): NCT00049673
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 16, 2002 Closing Date: January 30, 2009

Chair: (USA) Dr. Martha Q. Lacy, Mayo Clinic Rochester, (507) 284-8430


Permanently Closed
MY11A Randomized Phase II Dose Finding Study of Lenalidomide and Melphalan in Patients With Previously Untreated Multiple Myeloma
A Randomized Phase II Dose Finding Study of Lenalidomide and Melphalan in Patients With Previously Untreated Multiple Myeloma

Eligibility: Previously untreated patients with histologically confirmed myeloma who are not considered candidates for future peripheral blood stem cell autotransplantation by virtue of advanced age, co-morbid illness or patient preference.

Objectives: Primary: 1) To evaluate the tolerability of combination therapy with lenalidomide and melphalan in patients with previously untreated multiple myeloma not destined for future autologous stem cell transplant. Two starting doses of lenalidomide (15mg or 10mg days 1-21 each 28 day cycle) will be investigated. 2) To determine an estimate of the efficacy of the combination of melphalan and lenalidomide. The primary measure of efficacy will be the percentage of patients who, after completing six cycles of therapy, achieve a complete remission using European Group for Blood and Marrow Transplantation/International Bone marrow transplant registry criteria for remission assessment.

NCT Registration ID (from clinicaltrials.gov): NCT00305812
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 13, 2005 Closing Date: March 27, 2008

Chair: (Canada) Dr. Darrell White, QEII Health Sciences Centre, (902) 473-4642


Permanently Closed
MY2Continuing versus Stopping Therapy in Patients Stabilized on Melphalan and Prednisone
Continuing versus Stopping Therapy in Patients Stabilized on Melphalan and Prednisone

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 23, 1977 Closing Date: December 14, 1984

Permanently Closed
MY3Pilot Study of Weekly Cyclophosphamide and Prednisone Therapy for Patients Unresponsive to Melphalan and Prednisone Induction Therapy
Pilot Study of Weekly Cyclophosphamide and Prednisone Therapy for Patients Unresponsive to Melphalan and Prednisone Induction Therapy

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 01, 1982 Closing Date: September 01, 1984

Permanently Closed
MY4Etidronate Disodium (EHDP) Versus Placebo in the Treatment of Multiple Myeloma
Etidronate Disodium (EHDP) Versus Placebo in the Treatment of Multiple Myeloma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 19, 1983 Closing Date: February 28, 1987

Permanently Closed
MY5Modified VAD (m-VAD-VINCRISTINE, ADRIAMYCIN, DEXAMETHASONE) in Primary Refractory and Relapsed Plasma Cell Myeloma
Modified VAD (m-VAD-VINCRISTINE, ADRIAMYCIN, DEXAMETHASONE) in Primary Refractory and Relapsed Plasma Cell Myeloma

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 28, 1986 Closing Date: October 17, 1989

Permanently Closed
MY6Clinical Trial of Interferon versus no Additional Treatment in Multiple Myeloma Patients Who Have Responded to Melphalan and Prednisone
Clinical Trial of Interferon versus no Additional Treatment in Multiple Myeloma Patients Who Have Responded to Melphalan and Prednisone

NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 04, 1987 Closing Date: June 26, 1992

Permanently Closed
MY7A Comparative Study of Dexamethasone versus Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone versus no Additional Treatment as Maintenance Therapy in Non-Progressing Patients
A Comparative Study of Dexamethasone versus Prednisone (Both in Combination With Melphalan) as Induction Therapy in Untreated Symptomatic Myeloma With an Additional Assessment of Dexamethasone versus no Additional Treatment as Maintenance Therapy in Non-Progressing Patients

Eligibility: Patient with newly diagnosed, histologically proven, untreated, symptomatic Stage I or Stage II or III myeloma, with either a measurable serum M-protein or Bence Jones M-protein of >1.0g/24h and an ECOG performance status of <4.

Objectives: To Compare overall survival between patients receiving M+P versus M+D as induction therapy and patients maintained by dexamethasone versus observation. To compare time progression, response rates, incidences of toxicities and quality of life with the same groups of patients.

NCT Registration ID (from clinicaltrials.gov): NCT00002678
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 02, 1995 Closing Date: July 16, 2003

Permanently Closed
MY8 (E1A95)A Phase III Study Of PSC-833 In Combination With Vincristine, Doxorubicin And Dexamethasone (PSC-833/VAD) vs VAD Alone In Patients With Relapsing Or Refractory Mutilple Myeloma
A Phase III Study Of PSC-833 In Combination With Vincristine, Doxorubicin And Dexamethasone (PSC-833/VAD) vs VAD Alone In Patients With Relapsing Or Refractory Mutilple Myeloma

NCT Registration ID (from clinicaltrials.gov): NCT00002878
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: July 28, 1997 Closing Date: May 10, 2000

Permanently Closed
MY9Randomized Phase II Dose Finding Study of Thalidomide and Prednisone as Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma
Randomized Phase II Dose Finding Study of Thalidomide and Prednisone as Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma

NCT Registration ID (from clinicaltrials.gov): NCT00006890
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 12, 2000 Closing Date: September 07, 2001

Permanently Closed