Comparing New Treatments for Newly Diagnosed Acute Myeloid Leukemia with an IDH2 Gene Mutation

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06672146

Provider View

This study is testing whether adding the drug enasidenib to the usual treatment of ASTX727 and venetoclax can help older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who can't have standard treatment, and who have a specific gene mutation called IDH2, to better fight the disease.

Patient Parameters

Program Overview

This trial is exploring if a new combination of drugs can improve treatment for patients with acute myeloid leukemia (AML) who have a specific change in their IDH2 gene. The study compares two treatments: one with ASTX727 and venetoclax, and another that adds enasidenib to these drugs. The goal is to see if the addition of enasidenib helps more patients achieve remission, meaning the cancer is no longer detectable. The drugs work by helping the body produce normal blood cells and by targeting cancer cells. Participants will receive these treatments in cycles and will be monitored through blood tests and bone marrow exams.

Description

The main goal of this study is to see if adding enasidenib to the treatment of ASTX727 and venetoclax is safe and helps more patients achieve remission, where no cancer is detectable. The study will also look at how long patients stay in remission, their overall survival, and any side effects they experience. Participants will be randomly assigned to one of two groups: one group will receive ASTX727 and venetoclax, while the other group will receive these drugs plus enasidenib. All treatments are given in cycles, and patients will have regular check-ups, including blood tests and bone marrow exams, to monitor their progress. After finishing the treatment, patients will have follow-up visits to track their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be part of the MYELOMATCH program and have an IDH2 gene mutation.
  • Have newly diagnosed acute myeloid leukemia (AML) with a certain percentage of cancer cells in the blood or bone marrow.
  • Not currently receiving other experimental treatments.
  • Have not had previous treatment for AML, except for certain allowed medications.
  • Be 60 years or older, or 18 years or older if not eligible for standard treatment.
  • Have a performance status score of 0 to 3, indicating varying levels of activity.
  • Have normal liver and kidney function based on specific tests.
  • Not have a prolonged QT interval on an ECG, unless treated under a different protocol.
  • Have adequate heart function as assessed by a doctor.
  • If HIV-positive, be on effective treatment with an undetectable viral load.
  • If previously infected with hepatitis B or C, have controlled or cured infection.
  • Not have other cancers that could interfere with this study.
  • Not be pregnant or nursing, and agree to use effective contraception if of reproductive potential.
  • Be able to swallow pills and have no digestive issues that affect medication absorption.
  • Agree to provide samples for research purposes and consent to participate in the study.

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