CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 282 enrolled
Drug / intervention
Clofarabine +3 moredrug
Likely dose
Clofarabine 15 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/NCT01289457
NCT01289457Phase 2Completed
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Phase I/II Randomized Study of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome

M.D. Anderson Cancer Center·interventional·Posted Feb 3, 2011·Updated Feb 24, 2020

In Brief

A Phase 2 clinical trial evaluating Clofarabine, Idarubicin, and 2 other interventions for Leukemia. Completed, enrolled 282 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinations will also be studied.

Study Details

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

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2011
Enrollment StartFeb 2, 2011
Primary CompletionJun 28, 2017
TodayJul 1, 2026
Enrollment to primary: 6.4 yearsPosted 15.4 years ago

Interventions

Clofarabinedrug

Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle. Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle.

Idarubicindrug

10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.

Cytarabinedrug

1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.

Fludarabinedrug

30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).