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A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

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A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Feb 2025

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At a glance

  • Drugs Blinatumomab (Primary) ; Calaspargase pegol (Primary) ; Crisantaspase (Primary) ; Crisantaspase (Primary) ; Cyclophosphamide (Primary) ; Cytarabine (Primary) ; Cytarabine (Primary) ; Daunorubicin (Primary) ; Dexamethasone (Primary) ; Dexamethasone (Primary) ; Dexamethasone (Primary) ; Doxorubicin (Primary) ; Folinic acid (Primary) ; Folinic acid (Primary) ; Folinic acid (Primary) ; Hydrocortisone (Primary) ; Mercaptopurine (Primary) ; Mercaptopurine (Primary) ; Methotrexate (Primary) ; Methotrexate (Primary) ; Methotrexate (Primary) ; Methotrexate (Primary) ; Pegaspargase (Primary) ; Pegaspargase (Primary) ; Prednisolone (Primary) ; Prednisolone (Primary) ; Prednisone (Primary) ; Prednisone (Primary) ; Tioguanine (Primary) ; Tioguanine (Primary) ; Venetoclax (Primary) ; Venetoclax (Primary) ; Vincristine (Primary)
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Therapeutic Use

    • Most Recent Events

    • 29 Jan 2025 Planned initiation date changed from 26 Jan 2025 to 26 Apr 2025.
    • 15 Oct 2024 Planned End Date changed from 21 Dec 2027 to 31 Dec 2028.
    • 15 Oct 2024 Planned primary completion date changed from 21 Dec 2027 to 31 Dec 2028.

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