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Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

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Trial Profile

Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 06 Jan 2025

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At a glance

  • Drugs Blinatumomab (Primary) ; Antineoplastics; Antineoplastics; Antineoplastics; Antineoplastics; Asparaginase; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone; Doxorubicin; Filgrastim; Filgrastim; Hydroxycarbamide; Idarubicin; Mercaptopurine; Methotrexate; Methotrexate; Pegaspargase; Pegfilgrastim; Prednisolone; Prednisone; Rituximab; Vincristine
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms Golden Gate Study
  • Sponsors Amgen

    • Most Recent Events

    • 06 Sep 2024 Planned End Date changed from 6 Oct 2031 to 30 Sep 2031.
    • 06 Sep 2024 Planned primary completion date changed from 5 Jan 2027 to 30 Dec 2026.
    • 01 Aug 2024 Planned End Date changed from 2 Mar 2031 to 6 Oct 2031.

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