CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Decitabine +3 moredrug
Likely dose
Decitabine 20 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/NCT01794702
NCT01794702Phase 2Completed
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Phase I/II Study of Decitabine (DAC) Followed by Clofarabine, Idarubicin, and Cytarabine (CIA) in Acute Leukemia

M.D. Anderson Cancer Center·interventional·Posted Feb 20, 2013·Updated May 30, 2019

In Brief

A Phase 2 clinical trial evaluating Decitabine, Idarubicin, and 2 other interventions for Leukemia. Completed, enrolled 65 participants across 1 site.

Detailed Summary

The goal of Phase I of this clinical research study is find the highest tolerable dose of clofarabine that can be given with decitabine, idarubicin, and cytarabine to patients with acute leukemia. The goal of Phase II of this study is to learn if decitabine followed by the combination of clofarabine, idarubicin, and cytarabine can help to control acute leukemia. The safety of this drug combination will also be studied. Decitabine and idarubicin are designed to damage the DNA (the genetic material of cells). This may cause cancer cells to die. Clofarabine is designed to interfere with the growth and development of cancer cells. Cytarabine is designed to insert itself into DNA and stop the DNA from repairing itself.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 20, 2013
Enrollment StartFeb 20, 2013
Primary CompletionJan 11, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.4 years ago

Interventions

Decitabinedrug

Phase I and II - 20 mg/m2 by vein daily for 5 days (days 1-5)

Idarubicindrug

Phase I and II - 10 mg/m2 by vein daily for 3 days (days 6-8)

Cytarabinedrug

Phase I and II - 1 g/m2 by vein daily for 5 days (days 6-10)

Clofarabinedrug

Phase I Starting Dose - 15 mg/m2 by vein daily for 4 days (days 6-9) Phase II Starting Dose - Maximum tolerated dose from Phase I (number of days selected based on Phase I portion).