At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 60 enrolled

Drug / intervention

Clofarabinedrug

Likely dose

Clofarabine 15 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00422032

NCT00422032Phase 2Completed

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Phase II Randomized Study of Two Different Schedules of Intravenous Clofarabine in Myelodysplastic Syndrome (MDS)

M.D. Anderson Cancer Center·interventional·Posted Jan 15, 2007·Updated Jul 27, 2012

In Brief

A Phase 2 clinical trial evaluating Clofarabine for Myelodysplastic Syndrome and Leukemia. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMyelodysplastic Syndrome, Leukemia

CountriesUnited States

CollaboratorsGenzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2006

First PostedJan 2007

Primary CompletionNov 2011

TodayJul 2026

First PostedJan 15, 2007

Enrollment StartJan 1, 2006

Primary CompletionNov 1, 2011

TodayJul 2, 2026

Enrollment to primary: 5.8 yearsPosted 19.5 years ago

Interventions

Clofarabinedrug

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