CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Idarubicin +2 moredrug
Likely dose
Not stated in 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/NCT00831766
NCT00831766Phase 2Completed
CompareCT.gov

A Phase 1/2 Study of Sequential Idarubicin + Cytarabine, Followed by Lenalidomide, in Patients With Myelodysplastic Syndrome (RAEB-2) or With Previously Untreated Acute Myeloid Leukemia

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Jan 29, 2009·Updated Dec 22, 2020

In Brief

A Phase 2 clinical trial evaluating Idarubicin, Cytarabine, and 1 other intervention for Myelodysplastic Syndrome and Acute Myeloid Leukemia. Completed, enrolled 51 participants across 2 sites.

Detailed Summary

The purpose of this study is to: * Test the safety of the research study drug, lenalidomide, when given with Idarubicin and Cytarabine * See how many respond to combination treatment with lenalidomide, Idarubicin and Cytarabine * See how long people respond to this combination therapy * See how long people live after being treated with this combination of drugs

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, Acute Myeloid Leukemia
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2009
Enrollment StartJun 25, 2009
Primary CompletionFeb 17, 2015
Study CompletionNov 16, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 17.4 years ago

Interventions

Idarubicindrug

Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Cytarabinedrug

Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide (Revlimid®)drug

Lenalidomide as outlined in Phase I and Phase II Treatment Arms.