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Clinical trial

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

NCT04501614 is registered in ClinicalTrials.gov with Takeda as lead sponsor.

NCT NCT04501614
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Takeda
Phase
Phase 1/2
Overall status
Terminated
Start date
February 24, 2021
Completion date
July 19, 2024
Enrollment
11 (actual)
Sites
64

Conditions

As the registry lists them; a condition with its own page is linked.

pediatric philadelphia chromosome-positive acute lymphoblastic leukemia (ph+all), ph+ mixed phenotype acute leukemia (mpal), philadelphia chromosome-like all (ph-like all)