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Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia

Trying new cancer drugs with usual chemo for infant leukemia.

Recruiting
365 years and younger
All
Phase 2

This study is exploring if adding two anti-cancer drugs, Venetoclax and Blinatumomab, to the usual chemotherapy can better treat infants with a type of blood cancer called acute lymphoblastic leukemia (ALL). Venetoclax helps stop cancer cells by blocking a protein they need, while Blinatumomab is a special antibody that helps prevent cancer from spreading. The study will check if these drugs are safe and if they help more than standard chemotherapy alone.

  • Participation Length: The study lasts up to 2 years, with various treatment phases.
  • Visits Required: Patients will need multiple hospital visits for treatments and check-ups.
  • Potential Risks: Adding these drugs may lead to more side effects compared to standard treatment alone.

Children under 1 year with newly diagnosed ALL, who meet certain criteria, can join. The study involves regular checks like blood tests and heart scans. After treatment, follow-up will continue for up to 3 years to monitor the long-term effects.

Study details
    Acute Leukemia of Ambiguous Lineage
    B Acute Lymphoblastic Leukemia

NCT06317662

National Cancer Institute (NCI)

7 March 2026

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