drugset / Trial / NCT04070443

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

NCT04070443

Phase 2 Active not recruiting 170 enrolled Centre Leon Berard
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2019-11-13
Primary completion
2029-06-01
Completion
2029-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg Oral
Subject Ponatinib Small molecule 30 mg Oral