CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 282 enrolled
Drug / intervention
Azacitidine +3 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/NCT01522976
NCT01522976Phase 2Active

A Randomized Phase II/III Study of Azacitidine in Combination With Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination With Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

National Cancer Institute (NCI)·interventional·Posted Feb 1, 2012·Updated May 29, 2026

In Brief

A Phase 2 clinical trial evaluating Azacitidine, Laboratory Biomarker Analysis, and 2 other interventions for Chronic Myelomonocytic Leukemia and 6 related conditions. Active but no longer recruiting, targeting 282 participants across 294 sites in 2 countries.

Detailed Summary

This randomized phase II/III trial studies how well azacitidine works with or without lenalidomide or vorinostat in treating patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Lenalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether azacitidine is more effective with or without lenalidomide or vorinostat in treating myelodysplastic syndromes or chronic myelomonocytic leukemia.

Study Details

Timeline

Phase 2Active
2012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 1, 2012
Enrollment StartMar 1, 2012
Primary CompletionJun 1, 2015
Study CompletionMar 31, 2027
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.4 years ago

Interventions

Azacitidinedrug

Given SC or IV

Laboratory Biomarker Analysisother

Correlative studies

Lenalidomidedrug

Given PO

Vorinostatdrug

Given PO