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Spots Global Cancer Trial Database for Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

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Trial Identification

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

Official Title: A Multicentre, Open-label Phase II Trial Evaluating the Safety and Efficacy of Ponatinib Induction Followed by Imatinib Maintenance in Adult Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) ≤ 65 Years

Study ID: NCT04070443

Interventions

Ponatinib
Imatinib

Study Description

Brief 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.

Detailed Description: TREATMENT PLAN : All eligible patients will be treated: * During the induction Phase (Month 1 to Month 6) with ponatinib (30mg/day) single agent; then * During the consolidation Phase (Month 7 to Month 36) with imatinib (400mg/day) single agent; then * From M36 : * Patients with stable MR4.5 (i.e. since at least 2 years) will enter in the TFR phase and will stop imatinib treatment. Thereafter, in case of MMR loss, imatinib will be re-introduced as per investigator judgement (including for dose). * Patients without stable MR4.5 will continue imatinib treatment until stable MR4.5, or M60, PD, death, withdrawal of consent or overall trial completion. Such patients will be allowed to enter into the TFR phase as soon as a stable 2-year MR4.5 is reached: however, they will be considered as a failure for the primary endpoint analysis. STATISTICS : A total of 170 patients will be enrolled in this study. According to a Fleming design, with a P0=20% as minimal efficacy rate and P1=30% as an expected target, 156 patients should be enrolled, assuming an unilateral type I error alpha of 5% and 90% power. At the time of analysis, if at least 40 successes are observed among the 156 evaluable patients, the treatment will be considered as interesting for further investigation in this indication. Considering that some patients may withdraw their consent before 36 months (about 10%), the investigators plan to enrol 170 patients in total. DATA ENTRY, DATA MANAGEMENT AND STUDY MONITORING All the data concerning the patients will be recorded in the electronic case report form (eCRF) throughout the study. Serious adverse event (SAE) and Adverse Event of Specific Interest (AESI) reporting will be also paper-based by e-mail and/or Fax. The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol, Good Clinical Practices (GCP) and local law requirements.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Chu Amiens Picardie, Amiens, , France

CHU d'Angers, Angers, , France

Centre Hospitalier Annecy-Genevois, Annecy, , France

CH d'Avignon, Avignon, , France

Chru Besançon, Besançon, , France

Institut Bergonie, Bordeaux, , France

Chru Brest, Brest, , France

Institut D'Hematologie de Basse Normandie, Caen, , France

Chu D'Estaing, Clermont-Ferrand, , France

Centre Hospitalier Sud Francilien, Corbeil-Essonnes, , France

Hopital Henri Mondor, Créteil, , France

CHU de Grenoble, Grenoble, , France

CH de Versailles - Hôpital André Mignot, Le Chesnay, , France

Hôpital Claude Huriez - CHRU de Lille, Lille, , France

CHU Limoges - Hôpital Dupuytren, Limoges, , France

Centre Léon Bérard, Lyon, , France

Institut Paoli Calmettes, Marseille, , France

Hopital Saint Eloi, Montpellier, , France

Chu Hotel Dieu, Nantes, , France

CHU Nîmes Caremeau - Institut de Cancérologie du Gard, Nîmes, , France

Hopital Saintantoine, Paris, , France

Chu Poitiers, Poitiers, , France

Chu - Hopital de Pontchaillou, Rennes, , France

Institut de Cancérologie Lucien Neuwirth, Saint-Priest-en-Jarez, , France

Institut de cancérologie Strasbourg Europe, Strasbourg, , France

Iuct Toulouse - Oncopole, Toulouse, , France

CHRU Nancy/Brabois, Vandœuvre-lès-Nancy, , France

Hopital Paul Brousse, Villejuif, , France

Contact Details

Name: Franck-Emmanuel NICOLINI, MD

Affiliation: Centre Leon Berard

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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