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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Franck-Emmanuel NICOLINI, MD
Affiliation: Centre Leon Berard
Role: PRINCIPAL_INVESTIGATOR