CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
5-Azacytidine +1 moredrug
Likely dose
5-Azacytidine 75 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/NCT01038635
NCT01038635Phase 2Completed
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Phase I/II Study of the Combination of 5-azacitidine With Lenalidomide in Patients With High Risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

M.D. Anderson Cancer Center·interventional·Posted Dec 24, 2009·Updated Feb 10, 2017

In Brief

A Phase 2 clinical trial evaluating 5-Azacytidine and Lenalidomide for Leukemia. Completed, enrolled 94 participants across 1 site.

Detailed Summary

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of lenalidomide that can be given in combination with azacitidine to patients with MDS or AML. The goal of Phase 2 of this study is to learn if the combination dose of azacitidine and lenalidomide found in Phase 1 can help to control MDS and/or AML. The safety of this drug combination will be studied in both Phases.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2009
Enrollment StartDec 1, 2009
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 16.5 years ago

Interventions

5-Azacytidinedrug

75 mg/m\^2 IV daily x 5 days on days 1 to 5.

Lenalidomidedrug

Starting dose 10 mg orally daily x 5 days on days 6 to 10.