Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years

Summary

Primary outcome measure: Evaluate the efficacy in terms of complete responses of induction therapy and first-line consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or more. The first efficacy objective is evaluate the overall remission rate (TRG), where general reference (RG) is defined as a patient who achieved complete remission (CR) or complete remission with inadequate platelet recovery (CPR). Secondary outcome measures: * To evaluate disease-free survival (DFS) * Evaluate the overall survival (OS) * To evaluate the safety and tolerability of clofarabine and duration, severity and relationship of adverse events (AEs) occurring during treatment * To assess the rate of mortality at 30 days (ie, the incidence of deaths occurring between Day 1 and Day 30 of induction cycle) * The incidence, intensity (according to the latest version of the CTCAE classification), duration, causality, severity and type of AA

Timeline

Start

2010-09

Primary completion

2012-02

Completion

2012-02

Publications

• Martinez-Cuadron D, Montesinos P, Oriol A, Salamero O, Vidriales B, Bergua J, Herrera P, Vives S, Sanz J, Carpio C, Rodriguez-Veiga R, Moscardo F, Sanz MA. Phase II trial to assess the safety and efficacy of clofarabine in combination with low-dose cytarabine in elderly patients with acute myeloid leukemia. Ann Hematol. 2014 Jan;93(1):43-6. doi: 10.1007/s00277-013-1914-y. Epub 2013 Oct 1.

Drugs

Indications