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A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation

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Trial Profile

A Pivotal Phase 1/2, Single-Arm, Open-label Study to Evaluate the Safety and Efficacy of Ponatinib With Chemotherapy in Pediatric Patients With Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Who Have Relapsed or Are Resistant or Intolerant to a Prior Tyrosine Kinase Inhibitor-Containing Therapy, or Who Have the T315I Mutation

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 19 Apr 2024

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At a glance

  • Drugs Cyclophosphamide (Primary) ; Cyclophosphamide (Primary) ; Cytarabine (Primary) ; Daunorubicin (Primary) ; Daunorubicin (Primary) ; Dexamethasone (Primary) ; Dexamethasone (Primary) ; Dexamethasone (Primary) ; Etoposide (Primary) ; Etoposide (Primary) ; Hydrocortisone (Primary) ; Methotrexate (Primary) ; Methotrexate (Primary) ; Pegaspargase (Primary) ; Pegaspargase (Primary) ; Ponatinib (Primary) ; Vincristine (Primary) ; Vincristine (Primary)
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Takeda; Takeda Development Center Americas
  • Most Recent Events

    • 17 Apr 2024 This trial has been completed in Portugal as per European Clinical Trials Database record.
    • 12 Mar 2024 This trial has been completed in Poland and Czech Republic, as per European Clinical Trials Database record.
    • 01 Mar 2024 Planned End Date changed from 27 Aug 2027 to 4 Jan 2027.
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