CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Clofarabine +1 moredrug
Likely dose
Clofarabine 10 mg/m2from 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/NCT01444742
NCT01444742Phase 2Completed

Clofarabine Plus Low-Dose Cytarabine for the Treatment of Patients With Higher-Risk Myelodysplastic Syndrome (MDS) Who Have Been Relapsing After, or Are Refractory to, Hypomethylator Therapy

M.D. Anderson Cancer Center·interventional·Posted Oct 3, 2011·Updated Jul 3, 2018

In Brief

A Phase 2 clinical trial evaluating Clofarabine and Cytarabine for Leukemia and Myeloproliferative Diseases. Completed, enrolled 81 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if clofarabine when given in combination with cytarabine can help to control myelodysplastic syndrome (MDS) after the disease could not be controlled with standard therapy. The safety of this treatment will also be studied. Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 3, 2011
Enrollment StartNov 16, 2011
Primary CompletionJan 29, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 14.7 years ago

Interventions

Clofarabinedrug

Induction: 10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5) Consolidation: 10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)

Cytarabinedrug

Induction: 20 mg subcutaneously twice daily for 7 days (days 1-7) Consolidation: 20 mg subcutaneously twice daily for 5 days (days 1-5)