Phase II Study of Revumenib for Leukemia with Increased HOX Gene Activity

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06229912

Provider View

This clinical trial is exploring whether the drug revumenib can help control certain types of leukemia that are linked to increased activity of HOX genes.

Patient Parameters

Program Overview

The aim of this study is to find out if revumenib, also known as SNDX-5613, can effectively manage leukemias that show increased activity of HOX genes. Researchers will also look at how well the drug clears remaining cancer cells, its impact on genetic abnormalities, and how long patients remain free of disease after treatment.

Description

This study is focused on evaluating the effectiveness of revumenib in treating leukemias associated with increased HOX gene activity. Researchers will measure how well the drug works by looking at several factors, including the clearance of remaining cancer cells, changes in genetic abnormalities, and the duration of response and survival rates after treatment. Additionally, the study will explore molecular markers that might predict how well the drug works or if resistance develops. The expression of HOX/MEIS1 will be evaluated as a potential marker of response, and the rate of mutations in the MEN1 gene will be assessed as a possible resistance mechanism.

Eligibility Criteria

Inclusion Criteria

  • Age 12 years or older and weigh at least 40 kg.
  • Good overall health with a performance status score of 2 or less.
  • Have relapsed or treatment-resistant acute leukemia with specific genetic changes linked to increased HOX gene activity.
  • White blood cell count must be below 25,000/uL at enrollment.
  • Heart function must be above 40%.
  • Adequate liver function, with specific limits on bilirubin and liver enzymes unless affected by leukemia.
  • Adequate kidney function with a filtration rate of 60 mL/min or higher.
  • Willingness to provide informed consent by the participant or their guardian.
  • Sufficient time since last treatment, with specific intervals for different therapies.
  • Women of childbearing potential must use effective contraception during and for 3 months after the study. Men must be sterile or use contraception during and for 3 months after the study.

Exclusion Criteria

  • Uncontrolled medical, laboratory, or psychiatric conditions that pose a risk.
  • Use of other cancer treatments during the study, except for specific exceptions like intrathecal chemotherapy for CNS leukemia or steroids for differentiation syndrome.
  • Severe gastrointestinal or metabolic conditions affecting drug absorption.
  • Active treatment for another cancer.
  • Active hepatitis B, C, or HIV infections.
  • Pregnant or breastfeeding women.
  • Active uncontrolled infections.
  • Recent serious heart conditions or strokes.
  • Abnormal heart rhythm measurements.
  • Conditions or treatments that might interfere with study results or participation.
  • Active central nervous system leukemia.
  • Use of immunosuppressive therapy post-transplant at screening, unless specific conditions are met.
  • Active graft-versus-host disease above a certain severity.

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