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Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients With High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Studying a treatment for certain high-risk blood cancers.

Recruiting
1-25 years
All
Phase 3

This study aims to see if adding **inotuzumab ozogamicin**, a special medicine that targets cancer cells, to usual chemotherapy can help patients with certain types of blood cancer, like **B-cell Acute Lymphoblastic Leukemia (B-ALL)**, **Mixed Phenotype Acute Leukemia (MPAL)**, and **B-lymphoblastic lymphoma (B-LLy)**. Chemotherapy is a treatment that uses drugs to kill cancer cells. The study will observe if patients do better with or without inotuzumab ozogamicin. Key drugs used include inotuzumab, a monoclonal antibody, and calicheamicin, a chemotherapy agent. Patients will undergo different phases of treatment, starting with Induction and Consolidation, followed by various maintenance phases. The study also checks if treating boys and girls for the same length of time works well and how to help patients stick to taking their medicine.

  • Duration: Participation can last up to 2 years.
  • Visits: Regular visits are required for treatment and follow-ups.
  • Risks: Includes potential side effects from chemotherapy drugs.
Study details
    B Acute Lymphoblastic Leukemia
    B Lymphoblastic Lymphoma
    Central Nervous System Leukemia
    Mixed Phenotype Acute Leukemia
    Testicular Leukemia

NCT03959085

Children's Oncology Group

1 April 2025

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