Phase 2 Trial of Enasidenib (AG-221) Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients With IDH2 Mutation
City of Hope Medical Center
Summary
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.
Description
PRIMARY OBJECTIVES: 1\. Evaluate the efficacy of enasidenib as post-HCT maintenance therapy in patients with mIDH2 AML, at 2-years post-HCT. SECONDARY OBJECTIVES: 1. Assess overall (OS) and leukemia-free survival (LFS) at 1 and 2 years post-HCT; 2. Estimate the cumulative incidence of chronic GVHD at 1 and 2 years post-HCT; 3. Estimate the cumulative incidence of relapse, non-relapse mortality (NRM), GVHD and relapse free survival (GRFS) at 1 and 2 years post-HCT. EXPLORATORY OBJECTIVES: 1. Monitor disease status among subset of patients with MRD positive disease when start to receive Ena…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Eastern Cooperative Oncology Group (ECOG) =\< 2 or Karnofsky performance status (KPS) \>= 70 * Recipients of allogeneic HCT - all stem cell sources including sibling, unrelated, mismatched related/unrelated, cord and haploidentical transplant patients will be included * Conditioning regimen: Investigator's choic…
Interventions
- DrugEnasidenib Mesylate
Given PO
Locations (2)
- City of Hope Medical CenterDuarte, California
- Moffitt Cancer CenterTampa, Florida