Study on Different Treatment Orders for Newly Diagnosed IDH Mutated AML Patients Not Suitable for Intensive Therapy

Sponsor: Alice Mims

Sponsor score: 0

ClinicalTrials ID:NCT05401097

Provider View

This clinical trial is exploring the best order of treatment for older patients with acute myeloid leukemia (AML) who have specific genetic changes and cannot undergo intensive therapy. The study compares two sequences of medications to see which is more effective.

Patient Parameters

Program Overview

This study is testing two different sequences of medications for treating older patients with acute myeloid leukemia (AML) that has specific genetic changes in the IDH1 or IDH2 genes. The medications being tested include ivosidenib and enasidenib, which target these genetic changes, and azacitidine plus venetoclax, which help stop cancer cell growth. Researchers want to find out which treatment order works best: starting with ivosidenib or enasidenib followed by azacitidine plus venetoclax, or the reverse order.

Description

The main goal of this study is to compare how well two different treatment sequences work for patients with newly diagnosed IDH1 or IDH2 mutated AML who are not candidates for intensive chemotherapy. Patients will be randomly assigned to one of two groups:

  • Group A: Patients will first receive an IDH inhibitor (ivosidenib for IDH1 mutations or enasidenib for IDH2 mutations) along with azacitidine, followed by venetoclax with azacitidine.
  • Group B: Patients will first receive venetoclax with azacitidine, followed by an IDH inhibitor with azacitidine.

The study will look at how long patients live without the disease getting worse, how long they survive overall, and how well they respond to the treatments. Researchers will also monitor side effects and see how many patients can go on to receive a bone marrow transplant.

Participants will be followed up regularly after completing the study treatment to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with newly IDH1 or IDH2 mutated acute myeloid leukemia (AML).
  • Not eligible for or have declined intensive induction therapy.
  • Have a performance status score of 0 to 2, meaning they are fully active or have some limitations but are still able to care for themselves.
  • Have adequate kidney and liver function as determined by specific blood tests.
  • Female participants of childbearing potential must agree to use effective birth control during the study and for 30 days after the last dose of study medication.
  • Male participants must agree to use effective birth control during the study and for 90 days after the last dose of study medication.
  • Willing to comply with study visits and procedures.

Exclusion Criteria

  • Have acute promyelocytic leukemia.
  • Have active leukemia in the central nervous system.
  • Have a history of other active cancers, except for certain skin cancers or other cancers that have been in remission for at least 5 years.
  • Have uncontrolled infections, including hepatitis B, hepatitis C, or HIV.
  • Are pregnant or breastfeeding.
  • Are participating in another clinical trial with a new treatment within 14 days before starting this study.
  • Have conditions that affect the ability to take oral medications, such as certain digestive diseases.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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