CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Decitabine +1 moredrug
Likely dose
Decitabine 20 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/NCT00903760
NCT00903760Phase 2Completed
CompareCT.gov

A Randomized Study of Decitabine Alternating With Clofarabine Versus Decitabine Until Failure in Patients With Higher Risk Myelodysplastic Syndromes (MDS)

M.D. Anderson Cancer Center·interventional·Posted May 18, 2009·Updated Nov 15, 2018

In Brief

A Phase 2 clinical trial evaluating Decitabine and Clofarabine for Myelodysplastic Syndrome. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if sequential administration of decitabine and clofarabine can help to control MDS better than decitabine alone. The safety of this drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2009
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 17.1 years ago

Interventions

Decitabinedrug

Decitabine 20 mg/m\^2 by vein daily over 1-2 hours for 5 days for both Group 1 and Group 2. Group 1 receives decitabine on Days 1-5 of Cycles 1-3, 7-9, 13-15, and 19-21; and Group 2 is on Days 1-5 of every cycle.

Clofarabinedrug

Clofarabine 10 mg/m\^2 by vein daily over 1-2 hours for 5 days on Days 1-5 of Cycles 4-6, 10-12, 16-18, and 22-24.