Enasidenib as Maintenance Therapy in Treating Patients With Acute Myeloid Leukemia With IDH2 Mutation After Donor Stem Cell Transplant

Acute Myeloid Leukemia Clinical Trial

Official title: Pilot Trial of Enasidenib (AG-221) Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients With IDH2 Mutation

Status Recruiting

Clinical Trial Summary

This phase I 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.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Evaluate the safety and tolerability of enasidenib mesylate as maintenance therapy in post hematopoietic cell transplantation (HCT) patients.

SECONDARY OBJECTIVES:

I. Assess overall and leukemia free survival in patients post allogeneic HCT. II. Estimate relapse incidence, non-relapse mortality, graft versus host disease (GVHD) and relapse free survival (GRFS) in patients receiving enasidenib mesylate maintenance therapy.

EXPLORATORY OBJECTIVES:

I. Monitor disease status among subset of patients with minimal residual disease (MRD) positive disease when starting to receive enasidenib mesylate by multiparameter flow cytometry post allogeneic HCT on patients bone marrow (BM) on days +100 and +365.

II. Investigate clearance of IDH2 mutation post HCT by next generation sequencing-polymerase chain reaction (NGS-PCR) testing on the bone marrow specimens on days +100 and +365 and in peripheral blood every 3 months till 2 year follow up.

III. Investigate mIDH2 variant allele fraction (VAF) by droplet digital PCR (ddPCR) BEAMing technology on bone marrow specimens on days +100 and +365.

OUTLINE:

Patients receive enasidenib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and periodically thereafter up to 2 years. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

• NCT number: NCT03728335
• Study type: Interventional
• Source: City of Hope Medical Center
• Status: Recruiting
• Phase: Phase 1
• Start date: July 11, 2019
• Completion date: January 11, 2027