Clinical Trial

Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

Study acronym: TIPI
Active, Not Recruiting Phase 2
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Summary
The investigators hypothesize that, in newly diagnosed de novo chronic phase CML patients, an induction treatment with ponatinib for 6 months should increase the rate of patients reaching a stable MR4.5 allowing cessation of imatinib treatment. The investigators proposal is to conduct a multicenter, Phase II trial to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib for 6 months, followed by a consolidation treatment with imatinib in newly diagnosed de novo chronic phase CML patients.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2019-08-26; most recent amendment 2025-11-17.
Status change: Recruiting → Active, Not Recruiting 2022-12-01
Status change: Active, Not Recruiting → Recruiting 2020-04-28
Status change: Recruiting → Active, Not Recruiting 2020-03-25
Status change: Not Yet Recruiting → Recruiting 2019-11-13
Trial Details
NCT Number NCT04070443
Lead Sponsor Centre Leon Berard
Conditions Philadelphia Chromosome Positive CML, BCR-ABL Positive Chronic Myelogenous Leukemia
Enrollment 170 participants
Start Date 2019-11-13
Primary Completion 2029-06-01 (estimated)
Study Completion 2029-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-18