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A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

Exploring Revumenib with chemotherapy for challenging leukemia cases.

Recruiting
1-6 years
All
Phase 2

Summary: This study is for infants and young children with a type of leukemia called KMT2A-rearranged (KMT2A-R) leukemia, which can return or not respond to treatment. Leukemia is a cancer of white blood cells. Revumenib is a new medicine that targets these leukemia cells. This study combines revumenib with chemotherapy to see if it's safe and effective. Chemotherapy uses medicines like vincristine and prednisone to kill cancer cells or stop them from growing.

  • Participants will take revumenib and undergo chemotherapy cycles, possibly for up to 12 cycles, each lasting 28 days.
  • The study requires regular visits for treatments and monitoring, including blood tests and scans.
  • This study aims to find the best dose, but risks like side effects from chemotherapy and revumenib are possible.

Children eligible for this study must be under 6 years old, have the specific type of leukemia, and meet other health criteria. They cannot have certain infections or health conditions. Parents must provide consent for participation. This research helps determine if this treatment could improve outcomes for children with tough-to-treat leukemia.

Study details
    Recurrent Acute Leukemia of Ambiguous Lineage
    Recurrent Acute Lymphoblastic Leukemia
    Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage
    Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia
    KMT2A-Rearranged
    Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia
    Recurrent Mixed Phenotype Acute Leukemia
    Refractory Acute Leukemia of Ambiguous Lineage
    Refractory Acute Lymphoblastic Leukemia
    Refractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage
    Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia
    KMT2A-Rearranged
    Refractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia
    Refractory Mixed Phenotype Acute Leukemia

NCT05761171

Children's Oncology Group

12 July 2025

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