Study on Enasidenib Maintenance Therapy After Stem Cell Transplant in Patients with IDH2 Mutation

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT03728335

Provider View

This clinical trial is exploring the use of enasidenib as a maintenance treatment for patients with acute myeloid leukemia (AML) who have an IDH2 mutation and have undergone a donor stem cell transplant. The study aims to see if enasidenib can help prevent the cancer from returning by blocking certain enzymes that cancer cells need to grow.

Patient Parameters

Program Overview

This phase II study is investigating the side effects and effectiveness of using enasidenib as a maintenance therapy for patients with acute myeloid leukemia (AML) who have an IDH2 mutation and have received a donor stem cell transplant. Enasidenib works by blocking enzymes that cancer cells need to grow, potentially stopping the cancer from coming back.

Description

The main goal of this study is to evaluate how effective enasidenib is as a maintenance therapy for patients with AML and an IDH2 mutation, two years after their stem cell transplant. Researchers will also look at overall survival rates and leukemia-free survival at one and two years after the transplant. They will assess the occurrence of chronic graft-versus-host disease (GVHD) and the rates of cancer relapse and non-relapse mortality.

Patients will take enasidenib by mouth once a day for 28 days, with treatment cycles repeating every 28 days for up to 24 cycles, as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits at 30 days and periodically for up to two years.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Agree to allow the use of previous tumor biopsy samples.
  • Have a performance status score indicating they are able to carry out daily activities.
  • Have received a donor stem cell transplant from any source, including sibling or unrelated donors.
  • Have acute myeloid leukemia (AML) with an IDH2 mutation and show remission with less than 5% cancer cells in the bone marrow after transplant.
  • May have had previous treatment with IDH2 inhibitors.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use birth control during the study and for three months after the last dose.

Exclusion Criteria

  • History of allergic reactions to similar drugs.
  • Significant uncontrolled illness or active infection requiring antibiotics.
  • Known history of HIV or hepatitis B or C infection.
  • Other active cancers, except for certain skin cancers or in-situ cervical cancer.
  • Pregnant or breastfeeding women.
  • Active grade II-IV acute GVHD requiring systemic steroids.
  • Any condition that the investigator believes would make participation unsafe.
  • Concerns about the ability to comply with study procedures.

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