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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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Trial Profile

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: Recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Jun 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

  • 06 May 2025 Planned number of patients changed from 171 to 153.
  • 06 May 2025 Planned initiation date changed (estimated date for recruitment of the first subject) to 20 Jan 2026
  • 06 May 2025 Status changed from not yet recruiting to recruiting.

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