NCIC Clinical Trials Group

Brain Gastro-Intestinal Gynecologic Hematologic Lung Sarcoma
Breast Genito-Urinary Head & Neck IND Melanoma Symptom Control

AL.5

(DFCI: 06-254)

Adult ALL Trial
(NCT01005758)

Adobe Acrobat is required to view protocols and forms.

Study Description
Summary / Status / Accrual

Study Contacts:
Eligibility, Treatment and Form Completion Questions:
Caroline Kokulis 617-632-6288

For questions regarding study logistics, Canadian site activation and drug supply please contact
Canadian Cancer Trials Group Study Coordinator:
Andrea Hiltz
613-533-6430

Canadian Cancer Trials Group Clinical Trials Assistant:
Amy Hawkins
613-533-6430

Canadian Cancer Trials Group Ethics Research Associate:
Centre Contact
613-533-6430

Untitled Document Safety Reports
Including IBs and PMs

Ethics Utility

Case Report Forms

Correlative Specimens

Drug / Agent Forms

PEG - Asparaginase Supply Forms

DSMC Reports

Spring Meeting 2014 Report

It is your responsibility to ensure that you have
the most recent versions of all documents.

Canadian Cancer Trials Group Appendix - Administrative Update #3 - 2013JAN18

Protocol - Amendment #34 - 2012JUL02

Notification of Trial Closure - 2013JAN08


Amendment Documentation
Central Activation Documentation
DFCI Guideline Documents
Deviations Policy - 2012FEB27
DFCI IRB Major Deviation - 2012FEB27
DFCI IRB Protocol Deviation Log
Adverse Event Reporting Guidelines - 2012FEB27
Consents - Amendment #34 - 2012OCT11
English: Word Version / Tracked PDF Version
French: Word Version / Tracked PDF Version

Participant Information Letter - 2014JAN07:
English / French
News / Notes / Misc.
Memo: Accrual Countdown - 2012DEC03
Memo: Accrual Countdown - 2012NOV19
Memo: Accrual Countdown - 2012OCT30
Memo: Holiday Shipping Memo - 2012JUN20
Protocol Slides - 2012MAR15
Study Summary - January 2012
Memo: Shortage of Cytarabine - 2011MAR11
Memo: Data Entry Reminder - 2010SEP16
Memo: Shortage of Cytarabine - 2010JUL22

Contact List

Amendment Documentation
Version Documentation Health Canada Documents
Participant Information Letter:
2014JAN07
Notification NA
Administrative Update #3 - 2013JAN18 Notification
Summary
---
Amendment #34: 2012JUL02 Memo: Correction - 2012NOV12
Notification
Protocol Summary
No Objection Letter (NOL)
REB Attestation Form
Amendment #31: 2011AUG01 Notification
Protocol Summary
Protocol
Appendix Summary Appendix
Consents:
English - Word / Tracked PDF
French - Word / Tracked PDF
No Objection Letter (NOL)
REB Attestation Form
Consent Form Update #2 - 2011JUN01 Notification
Consent: English / French
---
Amendment #21 & 25: 2010OCT20 Notification
Summary #21
Summary #25
Consents:
English - Word / Tracked PDF
French - Word / Tracked PDF
Canadian Cancer Trials Group Appendix
Protocol

Letter to Investigators - 2010OCT18
DSMC response to PI letter - October 2010
PI letter re: PEG dose changes - 2010OCT12

Accrual Suspension Notice - 2010SEP13
DFCI Suspension Letter DMC - 2010SEP10
No Objection Letter (NOL)
REB Attestation Form
Amendment #12: 2009JUN09
Amendment #22: 2010AUG25
Amendment #23: 2010AUG25
Cdn Appendix Update: 2010AUG25
Notification (Expedited)
Summary #12
Summary #22
Summary #23
Appendix Amendment #22
Protocol Amendments 22 & 23
Consents - Amendment #22:
English - Word / Tracked PDF
French - Word / Tracked PDF
No Objection Letter (NOL)
REB Attestation Form
Consent Form Update - 2009FEB27 Notification / Summary (Expedited)
Consents:
English - Word / Tracked PDF
French - Word / Tracked PDF
---
Amendment #7 - 2008OCT30 Notification / Summary (Expedited) ---

Central Activation Documentation
Version Documentation Health Canada Documents
2008MAR11 Notice of Central Activation
Generic Activation Forms
Participants List
Participants List Change Form
Randomization Log
No Objection Letter (NOL)
Qualified Investigator Undertaking (QIU)
REB Attestation Form

Case Report Forms
Eligibility Checklist
Treatment Ended/Off Study Form
SAE Reporting Form - 2013AUG23
Induction Anticoagulation & Monitoring Form - 2012MAR16
Consolidation Anticoagulation & Monitoring Form - 2012MAR16
Toxicity Event Thrombosis Form - 2012MAR16

Correlative Specimens
MRD Shipping Instructions
Processing Instructions for Serum Samples
MRD Sample Form
Serum Antibody & Enzyme Sample Form
Antibody Labels
Large Labels
Enzyme Labels
Asparaginase Enzyme Log

Drug / Agent Forms
Letter to Pharmicists - 2009MAY05
Investigational Agent Accountability Log
Drug Overlabel - ONCASPAR - 2008SEP12
Temperature Excursion Template

PEG - Asparaginase Supply Forms
Approved Lot Numbers - 2013NOV08
Clinical Request Authorization Form
Clinical Product Order Form

DSMC Reports
DSMC Report - 2015JAN23
Memo & DSMC Report of 2014JUN13
Memo & DSMC Report of 2014JAN16
Memo & DSMC Report of 2013JUN20
Memo & DSMC Report of 2013JAN24
Memo: DSMC Report of 2012Jun28
Memo & DMC Recommendations - January 2012
Memo: Recommendations - 2011FEB10 / DMC Report - February 2011
Memo: 2010SEP22 / Recommendations - September 2010
Memo: 2010FEB22 / Recommendations - 2010FEB12
2009MAR18

Use this to link back to CTG home only

If you have any questions, comments or suggestions, please contact our