Phase II Study of the Targeted Mutant IDH2 Inhibitor Enasidenib in Combination With Azacitidine for Relapsed/Refractory AML
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. To determine the clinical activity of enasidenib mesylate (AG221, IDHIFA) in combination with azacitidine (AZA) for patients with relapsed/refractory acute myeloid leukemia is measured by overall response rate (ORR). SECONDARY OBJECTIVES: I. To determine duration of response, event-free survival (EFS), and overall survival (OS). II. To determine the safety of enasidenib in combination with azacitidine in patients with relapsed/refractory acute myeloid leukemia (AML). EXPLORATORY OBJECTIVES: I. To evaluate occurrence of minimal residual disease (MRD) negative status…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with AML or biphenotypic or bilineage leukemia (including a myeloid component) who have failed prior therapy. Patients with isolated extramedullary AML are eligible. The World Health Organization (WHO) classification will be used for AML * Elderly (\> 60 years old) patients with newly diagnosed AML not eligible for intensive chemotherapy are also eligible * AML patients with prior history of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) regardless of prior therapy received, are eligible at the time of diagnosis of AML * Subjects must h…
Interventions
- DrugAzacitidine
Given SC or IV
- DrugEnasidenib Mesylate
Given PO
Location
- M D Anderson Cancer CenterHouston, Texas