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
Latest Information Update: 15 Jul 2024
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
- 12 Jul 2024 This trial has been suspended in Poland, according to European Clinical Trials Database record.
- 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.