CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 175 enrolled
Drug / intervention
Cytarabine +1 moredrug
Likely dose
Cytarabine 1.5 gfrom 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/NCT00422591
NCT00422591Phase 2Completed
CompareCT.gov

Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

M.D. Anderson Cancer Center·interventional·Posted Jan 17, 2007·Updated Aug 23, 2018

In Brief

A Phase 2 clinical trial evaluating Cytarabine and Idarubicin for Leukemia and 2 related conditions. Completed, enrolled 175 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML. Objectives: To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Acute Myeloid Leukemia, AML
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 17, 2007
Enrollment StartDec 1, 2006
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 10.1 yearsPosted 19.5 years ago

Interventions

Cytarabinedrug

1.5 g/m2 IV over 24 hours daily on day 1-4 (age \<60 years) or days 1-3 (age \> 60 years).

Idarubicindrug

12 mg/m2 IV over 1 hour daily x 3 (days 1-3)