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Clinical Trial Summary

This phase II trial studies how well enasidenib works in treating in patients with acute myeloid leukemia with an IDH2 gene mutation that has come back or has not responded to treatment. Enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. In this study we are investing if enasidenib can be used as maintenance therapy post salvage induction chemotherapy.


Clinical Trial Description

PRIMARY OBJECTIVES: I. Evaluate the effect of IDH2 inhibition following conventional high dose salvage chemotherapy with detectable IDH2 mutations on event free survival (EFS) in patients with relapsed/refractory acute myeloid leukemia (AML). SECONDARY OBJECTIVES: I. Evaluate the effect of IDH2 inhibitor maintenance therapy following intensive salvage therapy: i.e., rate of hematocrit (HCT), duration of maintenance therapy and overall survival in patients with IDH2 mutant relapsed/refractory AML. EXPLORATORY OBJECTIVES: I. Evaluate the changes in IDH2 mutational variant allelic frequency and deoxyribonucleic acid (DNA) methylation signature while on enasidenib therapy. OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT I: Patients receive enasidenib orally (PO) once daily (QD). Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo a hematopoietic cell transplantation (HCT) 7-14 days after treatment. Within 30-100 days following the transplant, patients receive enasidenib QD. Treatment repeats every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. COHORT II: Patients receive enasidenib PO QD. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 months and then yearly for 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03881735
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Withdrawn
Phase Phase 2
Start date December 2, 2019
Completion date November 19, 2022

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