Trial of Decitabine in Patients With Acute Myeloid Leukemia

Phase 3 Completed 485 enrolled Eisai Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the results in older patients who have newly diagnosed or secondary acute myeloid leukemia (AML) and who are to either receive decitabine or patient's choice with the physician's advice of either cytarabine or supportive care medication.

Timeline

Start: 2005-11
Primary completion: 2009-10
Completion: 2010-12

Outcome

Missed primary endpoint

registry analysis (unspecified test); Cytarabine or Supportive Care vs Dacogen (Decitabine) Only; p = 0.1079; Kaplan-Meier NCT00260832 ↗

Publications

Mayer J, Arthur C, Delaunay J, Mazur G, Thomas XG, Wierzbowska A, Ravandi F, Berrak E, Jones M, Li Y, Kantarjian HM. Multivariate and subgroup analyses of a randomized, multinational, phase 3 trial of decitabine vs treatment choice of supportive care or cytarabine in older patients with newly diagnosed acute myeloid leukemia and poor- or intermediate-risk cytogenetics. BMC Cancer. 2014 Feb 6;14:69. doi: 10.1186/1471-2407-14-69.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cytarabine	Small molecule	20 mg/m2	Subcutaneous
Comparator	Decitabine	Small molecule	20 mg/m2	Intravenous