Actively Recruiting
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
Led by M.D. Anderson Cancer Center · Updated on 2026-03-05
50
Participants Needed
1
Research Sites
469 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 how well enasidenib and azacitidine work in treating patients with IDH2 gene mutation and acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). Enasidenib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
CONDITIONS
Official Title
Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with AML or biphenotypic or bilineage leukemia (including a myeloid component) who have failed prior therapy
- Patients with isolated extramedullary AML are eligible
- Elderly patients over 60 years with newly diagnosed AML not eligible for intensive chemotherapy are eligible
- AML patients with prior myelodysplastic syndrome or chronic myelomonocytic leukemia are eligible at AML diagnosis
- Documented IDH2 gene mutation
- ECOG performance status of 0, 1, or 2
- Adequate kidney function with creatinine less than 2 unless related to disease
- Total bilirubin less than twice the upper limit of normal unless due to Gilbert's disease or leukemic involvement
- AST and/or ALT less than 3 times the upper limit of normal unless due to leukemic involvement
- Written informed consent provided
- Oral hydroxyurea and/or cytarabine (up to 2 g/m2) allowed before study therapy if needed
- CNS prophylaxis or continuation of therapy for controlled CNS disease allowed
- Females must be surgically or biologically sterile, postmenopausal for at least 12 months, or have a negative pregnancy test within 72 hours before treatment
- Women of childbearing potential must agree to use contraception during and for 3 months after treatment
- Males must be surgically or biologically sterile or agree to use contraception during and for 3 months after treatment
You will not qualify if you...
- Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (FAB class M3-AML)
- Active and uncontrolled infections or other comorbidities such as uncontrolled hypertension, congestive heart failure NYHA class III/IV, or significant arrhythmias
- Any medical, psychological, or social condition that may interfere with study participation or patient safety
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Courtney DiNardo
CONTACT
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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