5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia

Phase 2 Terminated 9 enrolled M.D. Anderson Cancer Center Celgene Corporation · collab

NaSingle-groupOpen-labelTreatment

Summary

The objective of this study is to determine the safety and efficacy of Azacytidine in fludarabine-resistant chronic lymphocytic leukemia (CLL), Richter's transformation, and T-cell prolymphocytic leukemia (T-PLL).

Timeline

Start: 2006-09
Primary completion: 2014-11
Completion: 2014-11

Outcome

Missed primary endpoint

Stopped (Enrollment): “Slow accrual.”

paper Although no partial or complete responses occurred in these heavily pretreated patients PMID 23265768 ↗

Publications

Results Malik A, Shoukier M, Garcia-Manero G, Wierda W, Cortes J, Bickel S, Keating MJ, Estrov Z. Azacitidine in fludarabine-refractory chronic lymphocytic leukemia: a phase II study. Clin Lymphoma Myeloma Leuk. 2013 Jun;13(3):292-5. doi: 10.1016/j.clml.2012.11.009. Epub 2012 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	5-Azacytidine	Small molecule	75 mg/m2	Subcutaneous