CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 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/NCT01025154
NCT01025154Phase 2Completed
CompareCT.gov

Clofarabine, Idarubicin, and Cytarabine Combination as Induction Therapy for Younger Patients With Acute Myeloid Leukemia (AML)

M.D. Anderson Cancer Center·interventional·Posted Dec 3, 2009·Updated Oct 9, 2018

In Brief

A Phase 2 clinical trial evaluating Clofarabine, Idarubicin, and 1 other intervention for Acute Myeloid Leukemia. Completed, enrolled 63 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2009
Enrollment StartJan 1, 2010
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.6 years ago

Interventions

Clofarabinedrug

Induction Cycle: 20 mg/m\^2 IV over approximately 1 hour daily for 5 days (days 1-5)

Idarubicindrug

Induction Cycle: 10 mg/m\^2 IV over approximately 30 minutes daily for 3 days (days 1-3), following clofarabine by 1 to 2 hours

Cytarabinedrug

Induction Cycle: 1 g/m\^2 IV over approximately 2 hours daily for 5 days (days 1-5), follow clofarabine by 3 to 6 hours.