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2 Arm Study of Clofarabine IV in MDS Patients

NCT00422032 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-07-27

Study results available
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Summary

The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared.

Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS.

Secondary Objective: Compare response durations, survivals and side effects of the two schedules.

Conditions

Interventions

DRUG

Clofarabine

Group A: 15 mg/m\^2 IV over 1 hour daily for 5 days Group B: 30 mg/m\^2 IV over 1 hour daily for 5 days

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Hagop Kantarjian, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00422032 on ClinicalTrials.gov