Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Phase 2 Completed 214 enrolled University Hospital Muenster Amgen · collab Celgene Corporation · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary purpose of the study is to determine, whether the addition of 5-azacytidine to standard chemotherapy in elderly patients with newly diagnosed AML improves treatment results (event free survival).

Timeline

Start: 2009-07
Primary completion: 2012-12
Completion: 2012-12

Publications

Krug U, Koschmieder A, Schwammbach D, Gerss J, Tidow N, Steffen B, Bug G, Brandts CH, Schaich M, Rollig C, Thiede C, Noppeney R, Stelljes M, Buchner T, Koschmieder S, Duhrsen U, Serve H, Ehninger G, Berdel WE, Muller-Tidow C. Feasibility of azacitidine added to standard chemotherapy in older patients with acute myeloid leukemia--a randomised SAL pilot study. PLoS One. 2012;7(12):e52695. doi: 10.1371/journal.pone.0052695. Epub 2012 Dec 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	37.5 mg/m2	Intravenous
Subject	Azacitidine	Other / unclassified	75 mg/m2	Intravenous
Comparator	Cytarabine	Small molecule	100 mg/m2	Intravenous
Comparator	Cytarabine	Small molecule	1 g	Intravenous
Comparator	Daunorubicin	Small molecule	60 mg/m2	Intravenous

Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Summary

Timeline

Publications

Drugs

Indications