OncoMatch/Clinical Trials/NCT03383575
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
Is NCT03383575 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
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)
Demographics
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 →Frequently asked questions
Is NCT03383575 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hypomethylating agent, IDH2 inhibitor disqualifies patients from enrollment.
Does this trial require IDH2?
Yes, IDH2 r140 is a required biomarker for enrollment.
Does this trial require IDH2?
Yes, IDH2 r172 is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify