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A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients with Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib

To demonstrate the efficacy of ponatinib administered at 2 starting doses (30 and 15 mg QD) compared to nilotinib administered at 400 mg BID in patients with CP-CML who are resistant to imatinib, as measured by MMR by 12 months

A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients with Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

Primary Objective:To characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in patients with CP-CML who are resistant to at least 2 TKIs, as measured by MCyR by 12 months.Key Secondary Objectives:* To…

A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

This phase 3 trial will test the hypothesis that ponatinib is an effective treatment for newly diagnosed CP-CML patients when compared with standard imatinib

Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO): a prospective, multicentre, single-arm study

Primary: To assess the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response.

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants.

This study has been transitioned to CTIS with ID 2023-509699-41-00 check the CTIS register for the current data. Primary objectives:Phase 1: To determine the MTD and/or RP2D of oral ponatinib administered QD in pediatric participants with selected…

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

Primary Objectives:Phase 1 Primary Objective** To determine the RP2D of ponatinib (tablet and AAF) in combination with chemotherapy.Phase 2 Primary Objective* * To determine the efficacy of ponatinib in combination with chemotherapy as measured by…