Study on Revumenib for Treating Relapsed or Refractory Leukemias with Specific Gene Changes

Sponsor: Syndax Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04065399

Provider View

This clinical trial is testing a new drug, Revumenib, to find the best dose and see if it is safe and effective for patients with certain types of leukemia that have returned or not responded to treatment. The study focuses on leukemias with specific gene changes, such as MLL/KMT2A rearrangement or NPM1 mutation.

Patient Parameters

Program Overview

The study is divided into two phases. In Phase 1, researchers will determine the safest and most effective dose of Revumenib for patients with acute leukemia. In Phase 2, the study will focus on how well Revumenib works and its safety over time in patients with specific types of leukemia, including those with certain gene changes.

Description

In Phase 1, participants will take Revumenib by mouth in increasing doses to find the safest and most effective dose. Participants will be divided into different groups based on whether they are taking other medications that might affect how Revumenib works.

In Phase 2, the study will look at how well Revumenib works in three specific groups of patients:

  • Group 2A: Patients with a type of leukemia called KMT2Ar acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia (MPAL).
  • Group 2B: Patients with KMT2A acute myeloid leukemia (AML).
  • Group 2C: Patients with NPM1m acute myeloid leukemia (AML).

Eligibility Criteria

Inclusion Criteria

  • Must have active acute leukemia with specific gene changes or detectable disease in the bone marrow.
  • For Phase 1, participants will be grouped based on other medications they are taking.
  • For Phase 2, must have relapsed or refractory leukemia with specific gene changes.
  • White blood cell count must be below 25,000/microliter at enrollment.
  • Must be 30 days old or older.
  • Must be in good general health with a performance status score of 0-2.
  • Any previous treatment side effects must be mild or resolved.
  • Must meet specific time requirements since last treatments, such as radiation, stem cell transplant, or immunotherapy.
  • Must have adequate organ function.
  • If able to have children, must agree to use effective birth control during the study and for 120 days after the last dose.

Exclusion Criteria

  • Cannot have a type of leukemia called acute promyelocytic leukemia.
  • Cannot have leukemia that has only returned outside the bone marrow (Phase 2 only).
  • Cannot have active disease in the central nervous system.
  • Cannot have HIV, hepatitis B, or C.
  • Cannot be pregnant or breastfeeding.
  • Cannot have certain heart conditions or a prolonged QT interval on an ECG.
  • Cannot have gastrointestinal issues that affect drug absorption.
  • Cannot have severe liver disease.
  • Cannot have active graft-versus-host disease.
  • Cannot have another active cancer within the last 2 years, except for certain skin cancers or low-grade lymphomas.
  • Cannot take medications that prolong the QT interval, except for certain allowed drugs.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.