MedTrace Logo

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

NCT01193400 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2014-04-07

No results posted yet for this study

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

Conditions

  • Acute Myelogenous Leukemia

Interventions

DRUG

Clofarabine

DRUG

Cytarabine

Sponsors & Collaborators

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

    collaborator OTHER

  • PETHEMA Foundation

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193400 on ClinicalTrials.gov