NCT03683433 Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation
| NCT ID | NCT03683433 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Acute Bilineal Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2018-09-18 |
| Primary Completion | 2027-09-20 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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 have documented IDH2 gene mutation * Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 * Adequate renal function including creatinine \< 2 unless related to the disease * Total bilirubin \< 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement * Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \< 3 x ULN unless cons
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