Study on Ivosidenib as Maintenance Treatment After Stem Cell Transplant for Acute Myeloid Leukemia

Sponsor: Massachusetts General Hospital

Sponsor score: 0

ClinicalTrials ID:NCT06707493

Provider View

This clinical trial is testing whether the drug ivosidenib can help prevent the return of acute myeloid leukemia (AML) in patients with a specific genetic mutation after they have undergone a stem cell transplant.

Patient Parameters

Program Overview

The study is exploring the use of ivosidenib, a drug that targets a specific mutation in the IDH1 gene, to see if it can help prevent the relapse of acute myeloid leukemia (AML) in patients who have undergone a stem cell transplant. The trial compares ivosidenib to a placebo (a substance with no active drug) to determine its effectiveness. The study will last about 3.5 years, including up to 24 months of treatment and 12 months of follow-up. Approximately 75 participants will be involved in this research, which is supported by the pharmaceutical company Servier.

Description

This study is designed to test if ivosidenib, a drug that targets a specific mutation in the IDH1 gene, can help prevent the return of acute myeloid leukemia (AML) after a patient has received a stem cell transplant. The study is a Phase II trial, meaning it is focused on evaluating the effectiveness and safety of the drug. Participants will be randomly assigned to receive either ivosidenib or a placebo, and neither the participants nor the researchers will know who is receiving which treatment (single-blinded). The study will take place at multiple centers and will involve regular evaluations and follow-up visits.

The U.S. Food and Drug Administration (FDA) has not yet approved ivosidenib for use after stem cell transplants, but it is approved for other uses. Participants will be involved in the study for about 3.5 years, including up to 24 months of treatment and 12 months of follow-up. The study is supported by Servier, a pharmaceutical company, which provides the drug and funding for the research.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with acute myeloid leukemia (AML) with a specific IDH1 mutation.
  • Aged between 18 and 75 years.
  • Scheduled to undergo a stem cell transplant for their leukemia.
  • In good general health with a performance status score of 0 to 2, meaning fully active or able to carry out light work.
  • Have normal organ and bone marrow function, including:
    • Neutrophil count of at least 1000/µL without recent growth factor support.
    • Platelet count of at least 50,000/µL without recent transfusion.
    • Liver enzymes and bilirubin levels within specified limits.
    • Kidney function with creatinine clearance of at least 40 mL/min.
  • Heart function with an ejection fraction of at least 40%.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last dose.
  • Ability to understand and sign a written informed consent document.

Exclusion Criteria

  • Have had a previous stem cell transplant.
  • Have relapsed or refractory leukemia as determined by recent bone marrow tests.
  • Have a history of other cancers unless they have been disease-free for at least 5 years or had certain non-threatening cancers.
  • Have active hepatitis B or C infections.
  • Have a history of severe heart problems or certain heart rhythm disorders.
  • Have a prolonged QT interval on an ECG or other factors that increase the risk of heart rhythm problems.
  • Have uncontrolled illnesses that would interfere with study participation.

Post-transplantation Pre-Treatment Criteria:

  • Treatment can start between 45 and 90 days after the stem cell transplant.
  • Must still be willing to participate in the study.
  • No severe infections requiring IV antibiotics within 7 days before starting treatment.
  • At least 70% of blood or bone marrow cells must be from the donor.
  • No severe graft versus host disease (GVHD) requiring high-dose steroids or increased immunosuppression.
  • Certain medications for GVHD prevention and treatment are allowed.
  • No evidence of leukemia relapse or residual disease.
  • Must have adequate blood counts and organ function before starting treatment.

Locations

FACILITYZIPCITYSTATE
Massachusetts General Hospital02114BostonMassachusetts
Dana Farber Cancer Institute02115BostonMassachusetts

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