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A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

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Trial Profile

A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2024

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At a glance

  • Drugs Ponatinib (Primary) ; Cytarabine; Dexamethasone; Imatinib; Methotrexate; Prednisone; Vincristine
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Registrational; Therapeutic Use
  • Acronyms PhALLCON
  • Sponsors Takeda; Takeda Oncology

    • Most Recent Events

    • 20 Mar 2024 According to a Takeda media release, the company announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia in combination with chemotherapy,the approval was supported by data from the PhALLCON study.
    • 12 Dec 2023 Results of subgroup analysis for efficacy, presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 27 Nov 2023 According to a Takeda media release, subgroup analysis from this trial will be presented at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego.
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