Overview

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

Status:
Terminated

Trial end date:
2012-02-01

Target enrollment:

Participant gender:

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

Phase:

Phase 2

Details

Lead Sponsor:

PETHEMA Foundation

Collaborator:

Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias

Treatments:

Clofarabine
Cytarabine