OncoMatch/Clinical Trials/NCT03383575
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
Is NCT03383575 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Azacitidine and Enasidenib for acute myeloid leukemia.
Treatment: Azacitidine · Enasidenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Required: IDH2 r140
Required: IDH2 r172
Allowed: ASXL1 mutation
Allowed: EZH2 mutation
Allowed: RUNX1 mutation
Allowed: TP53 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent (azacitidine, decitabine, SGI-110) — relapsed or refractory (Arm B only)
Subject must be relapsed or refractory to prior hypomethylating agent therapy, defined as prior receipt of 6 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapy
Cannot have received: hypomethylating agent (azacitidine, decitabine, SGI-110)
Exception: Arm A only
Subject must be hypomethylating agent naive (i.e. prior azacitidine, decitabine, SGI-110 is exclusionary)
Cannot have received: IDH2 inhibitor
Subject has received a prior targeted IDH2 inhibitor
Lab requirements
Kidney function
Serum creatinine ≤ 2 x ULN
Liver function
Serum bilirubin ≤ 2 x ULN (except for patients with Gilbert's disease); ALT and/or AST ≤ 3 x ULN
Serum bilirubin ≤ 2 x the upper limit of normal (ULN) (except for patients with Gilbert's disease); Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3 x the laboratory ULN; Serum creatinine ≤ 2 x the ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, Maryland
- Cleveland Clinic Foundation · Cleveland, Ohio
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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