Actively Recruiting
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
Led by M.D. Anderson Cancer Center · Updated on 2026-02-17
63
Participants Needed
3
Research Sites
475 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed, informed consent obtained before study procedures
- Diagnosis of myelodysplastic syndrome (MDS), including RAEB-T or chronic myelomonocytic leukemia (CMML)
- Presence of an IDH2 gene mutation (IDH2-R140 or R172) confirmed locally
- For Arm A: No prior treatment with hypomethylating agents like azacitidine, decitabine, or SGI-110
- For Arm A: High-risk MDS defined by specific scoring systems or high-risk molecular features
- For Arm B: Relapsed or refractory to prior hypomethylating agent therapy after at least 6 cycles
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Serum bilirubin less than or equal to 2 times the upper limit of normal (ULN), except Gilbert's disease
- ALT and/or AST less than or equal to 3 times the ULN
- Serum creatinine less than or equal to 2 times the ULN
- Able to understand and voluntarily sign informed consent and comply with protocol
- Resolved treatment-related non-hematological toxicities to grade 1 or less except hair loss
- Female patients of childbearing potential must have a negative pregnancy test and agree to use dual contraception during and 3 months after treatment; post-menopausal and sterilized females exempt
- Male patients must use effective barrier contraception during and for 3 months after treatment if sexually active with females of childbearing potential
You will not qualify if you...
- Any medical condition increasing risk for participation as judged by investigator
- Prior treatment with a targeted IDH2 inhibitor
- Psychiatric or mental disorders preventing informed consent or study participation
- Active uncontrolled infections including HIV or chronic hepatitis B or C
- Significant gastrointestinal conditions affecting drug absorption including prior gastrectomy
- Known active central nervous system disease including leptomeningeal involvement
- Impaired or significant cardiac conditions including severe heart failure or recent heart attack
- Corrected QT interval greater than 480 ms (510 ms if bundle branch block present)
- Nursing or pregnant women
- Known hypersensitivity to study drugs or their ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
2
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Active, Not Recruiting
3
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Courtney DiNardo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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