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A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)

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A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Imatinib Combined With Chemotherapy in Patients With Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2025

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At a glance

  • Drugs Olverembatinib (Primary) ; Antineoplastics; Imatinib
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use
  • Sponsors Ascentage Pharma

    • Most Recent Events

    • 05 Mar 2025 According to an Ascentage Pharma media release, olverembatinib, has been granted a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), for combination with low-intensity chemotherapy for the first-line treatment of newly-diagnosed patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
    • 24 Nov 2023 According to an Ascentage Pharma media release, first patient has been dosed in this trial.
    • 22 Sep 2023 Status changed from not yet recruiting to recruiting.

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