CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 enrolled
Drug / intervention
Clofarabine +2 moredrug
Likely dose
Clofarabine 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/NCT00778375
NCT00778375Phase 2Completed
CompareCT.gov

Clofarabine Plus Low-Dose Cytarabine Induction Followed by Consolidation of Clofarabine Plus Low-Dose Cytarabine Alternating With Decitabine in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

M.D. Anderson Cancer Center·interventional·Posted Oct 23, 2008·Updated Jul 14, 2016

In Brief

A Phase 2 clinical trial evaluating Clofarabine, Cytarabine, and 1 other intervention for Acute Myeloid Leukemia and Myelodysplastic Syndrome. Completed, enrolled 122 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsEisai Inc., Genzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 23, 2008
Enrollment StartOct 1, 2008
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.7 years ago

Interventions

Clofarabinedrug

20 mg/m\^2 by vein as a 1- to 2-hour intravenous infusion daily for 5 days.

Cytarabinedrug

20 mg subcutaneously twice daily for 10 days, administered 3 to 6 hours following the start of the clofarabine infusions.

Decitabinedrug

20 mg/m\^2 as a 1- to 2-hour infusion daily for 5 days.