CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 63 target
Drug / intervention
Azacitidine +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/NCT03383575
NCT03383575Phase 2RecruitingOn TrackUpdated 4mo ago
Long Recruiting
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Targeted Therapy With the IDH2-Inhibitor Enasidenib (AG221) for High-Risk IDH2-Mutant Myelodysplastic Syndrome

M.D. Anderson Cancer Center·interventional·Posted Dec 26, 2017·Updated Feb 17, 2026

In Brief

A Phase 2 clinical trial evaluating Azacitidine, Enasidenib, and 1 other intervention for Acute Myeloid Leukemia and 6 related conditions. Currently recruiting, targeting 63 participants across 3 sites.

Detailed Summary

This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Blasts 20-30 Percent of Bone Marrow Nucleated Cells, Chronic Myelomonocytic Leukemia, IDH2 Gene Mutation, Myelodysplastic Syndrome With Excess Blasts, Recurrent High Risk Myelodysplastic Syndrome, Refractory High Risk Myelodysplastic Syndrome
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI), Celgene

Timeline

Phase 2Recruiting
2018201920202021202220232024202520262027
First PostedDec 26, 2017
Enrollment StartJan 17, 2018
Primary CompletionFeb 28, 2027
TodayJul 1, 2026
Enrollment to primary: 9.1 yearsPosted 8.5 years agoPrimary completion in 8 months

Interventions

Azacitidinedrug

Given IV or SC

Enasidenibdrug

Given PO

Quality-of-Life Assessmentother

Ancillary studies