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Permanent Trial Closure: ALC2

Permanent Trial Closure: ALC2
Please be aware of the permanent trial closure of the 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) trial.
 
The permanent closure letter can be found under the toolbox - Reports - Trial Closure here: https://www.ctg.queensu.ca/docs/trials/permanent_closure/ALC2-IG-Led-Perm-Closure-Letter_2024Feb14.pdf
 
The purpose of this study was to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research was done  because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. 

CONCLUSIONS: Gilteritinib resulted in significantly longer survival and higher percentages of patients with remission than salvage chemotherapy among patients with relapsed or refractory FLT3-mutated AML.