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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: 23 Jun 2025

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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 Development Center Americas; Takeda Oncology

Most Recent Events

  • 01 Jun 2025 Results assessing patient-reported outcomes (PRO) from PhALLCON assessed as exploratory endpoints using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) and EQ-5D-5L, published in the Leukemia.
  • 30 Apr 2025 Results(n=238) evaluating Impact of clinical response and treatment tolerability on HRQoL in patients treated with ponatinib or imatinib presented at the 116th Annual Meeting of the American Association for Cancer Research.
  • 25 Nov 2024 According to a Takeda media release, Results from two post-hoc analyses from the Phase 3 PhALLCON trial evaluating ICLUSIG versus imatinib plus reduced-intensity chemotherapy will at the 66th American Society of Hematology (ASH) Annual Meeting being held December 7-10, 2024, in San Diego, California.

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