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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: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 21 Jan 2025

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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

  • 15 Jan 2025 Status changed to discontinued as phase 1 enrollment was terminated due to dose-limiting toxicities, thus the study was terminated by Sponsor
  • 08 Aug 2024 Status changed from active, no longer recruiting to completed.
  • 02 Aug 2024 This trial has been Discontinued in Portugal, according to European Clinical Trials Database record.

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