High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML

Phase 3 Completed 398 enrolled Cooperative Study Group A for Hematology

RandomizedParallel-groupOpen-labelTreatment

Summary

Determine the effects of escalated dose of daunorubicin in induction treatment of adult patients with acute myelogenous leukemia who are younger than 60 years of age.

Timeline

Start: 2001-08
Primary completion: 2008-08
Completion: 2010-04

Publications

Lee JH, Joo YD, Kim H, Bae SH, Kim MK, Zang DY, Lee JL, Lee GW, Lee JH, Park JH, Kim DY, Lee WS, Ryoo HM, Hyun MS, Kim HJ, Min YJ, Jang YE, Lee KH; Cooperative Study Group A for Hematology. A randomized trial comparing standard versus high-dose daunorubicin induction in patients with acute myeloid leukemia. Blood. 2011 Oct 6;118(14):3832-41. doi: 10.1182/blood-2011-06-361410. Epub 2011 Aug 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daunorubicin	Small molecule	45 mg/m2	Intravenous
Subject	Daunorubicin	Small molecule	90 mg/m2	Intravenous
Background	Cytarabine	Small molecule	200 mg/m2	Intravenous

High Dose Daunorubicin Vs. Standard Dose Daunorubicin in Induction Treatment of AML

Summary

Timeline

Publications

Drugs

Indications