Actively Recruiting
Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation
Led by City of Hope Medical Center · Updated on 2026-03-13
35
Participants Needed
2
Research Sites
391 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical 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 of using enasidenib as maintenance therapy in treating patients with acute myeloid leukemia with IDH2 mutation following donor stem cell transplant. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
CONDITIONS
Official Title
Enasidenib (AG-221) Maintenance Post Allogeneic HCT in Patients With IDH2 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent or had a legally authorized representative consent
- Agree to allow use of existing tumor biopsy tissue or have approval for exception
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2 or Karnofsky performance status of 70 or higher
- Received allogeneic hematopoietic cell transplantation (HCT) from any stem cell source
- Conditioning and graft-versus-host disease (GVHD) prophylaxis per investigator's choice
- Diagnosed with acute myeloid leukemia (AML) with IDH2 mutation and showing less than 5% bone marrow blasts around day 30 post transplant
- Patients with measurable residual disease allowed
- Previous therapy with IDH2 inhibitors allowed
- Absolute neutrophil count greater than 1000 within 28 days before treatment start
- Hemoglobin level of at least 9.5 gm% within 28 days before treatment start
- Platelet count above 50,000/mm3 or at least 20,000/mm3 if actively treating infections within 28 days before treatment start
- Total bilirubin less than or equal to 1.5 times upper limit of normal, or less than 2.0 mg/dl if Gilbert's syndrome, within 28 days before treatment
- Liver enzymes (AST/ALT) less than or equal to 2 times upper limit of normal and no active GVHD related liver issues
- Creatinine clearance of at least 40/min/1.73 m2 within 28 days before treatment
- Corrected QT interval less than or equal to 480 ms within 28 days before treatment
- Negative tests for HIV, hepatitis B and C, and syphilis
- Women of childbearing potential must have a negative pregnancy test and agree to effective birth control or abstain during the study and for 3 months after
- Men of childbearing potential must agree to effective birth control or abstain during the study and for 3 months after
You will not qualify if you...
- History of allergic reactions to similar compounds as enasidenib
- Active diarrhea that prevents taking oral medication
- Uncontrolled serious illness
- Active infection requiring antibiotics (treated infections allowed if controlled)
- Known HIV or hepatitis B or C infection
- Diagnosis of Gilbert's disease
- Other active cancers except certain treated cancers in remission for over 2 years
- Pregnant or breastfeeding women
- Active grade II-IV acute graft-versus-host disease requiring high-dose steroids
- Any condition that in the investigator's judgment would prevent safe study participation
- Inability to comply with study procedures as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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