A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia

Sponsor
Children's Oncology Group
Study ID
NCT07498465
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Days - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Cytarabine — DRUG
    Given IT
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Methotrexate — DRUG
    Given IT
  • Radiologic Examination — PROCEDURE
    Undergo radiologic assessment
  • Revumenib — DRUG
    Given PO or via NG- or G-tube
  • Therapeutic Hydrocortisone — DRUG
    Given IT

Study Details

This phase I trial tests the safety, best dose, and effectiveness of revumenib given as maintenance therapy after standard hematopoietic stem cell transplant (HSCT) in patients with acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia. Revumenib binds to a protein called menin, which prevents menin from interacting with another protein called MLL. This results in an inhibition of the proliferation of leukemic cells with certain genetic alterations. Revumenib may inhibit the survival, growth, transformation and proliferation of certain kinds of leukemia cells. It is approved for the treatment of patients with certain types of acute leukemia, but it is not approved for maintenance therapy (treatment that aims to prevent cancer from coming back) after HSCT.

Key Dates

Start date
Sep 10, 2026
Status verified
Apr 2026
Primary completion
Nov 12, 2028
Completion
Nov 12, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (revumenib)
    Starting 42-100 days after HSCT, patients receive revumenib PO or via NG- or G-tube every 12 hours on days 1-28 of each cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive optional intrathecal therapy (methotrexate IT or cytarabine IT or methotrexate, hydrocortisone, and cytarabine IT) at the discretion of the physician on study. Patients also undergo bone marrow biopsy/aspiration and collection of blood samples throughout the trial. Patients may undergo ECHO and radiologic assessment as clinically indicated.

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: During cycles 1 and 2 (cycle length = 28 days) ]

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