drugset / Trial / NCT01145846

Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML)

NCT01145846

Phase 3 Unknown 316 enrolled Cooperative Study Group A for Hematology
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this non-inferiority study is to compare the effectiveness of two induction chemotherapy regimens (cytarabine plus idarubicin \[AI\] versus cytarabine plus high-dose daunorubicin \[AD\]) in AML. The effectiveness will be evaluated in terms of complete remission (CR) rate.

Timeline

Start
2010-05
Primary completion
2012-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 200 mg/m2 Intravenous
Subject Cytarabine Small molecule 1 g Intravenous
Subject Cytarabine Small molecule 3 g Intravenous
Subject Daunorubicin Small molecule 45 mg/m2 Intravenous
Subject Daunorubicin Small molecule 90 mg/m2 Intravenous