TIPI = Ponatinib followed by Imatinib in Chronic Phase Chronic Myeloid Leukemia [France]

Study title

Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (ET18000120; TIPI)

Scientific 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 (ClinicalTrials.gov no NCT04070443)

Indication and most important inclusion criteria

This study includes patients aged 18 to 65 years who were diagnosed with Philadelphia chromosome-positive (Ph+) with or without additional chromosomal abnormalities and/or BCR-ABL positive chronic myeloid leukemia (CML) in chronic phase (CP) within the past 2 months. Except for hydroxyurea and/or anagrelide, patients must have received no prior treatment for CML. To be eligible for inclusion, patients must also have a an intermediate or high EUTOS long-term survival Score. Kidney and liver function must be adequate.

Other criteria may apply.

Short description of intervention

This study is conducted to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib 30 mg/day for 6 months, followed by a consolidation treatment with imatinib 400 mg/day in newly diagnosed de novo chronic phase CML patients.

The aim is to determine whether this treatment sequence increases the rate of patients reaching a stable MR4.5 allowing discontinuation of imatinib treatment.

Type of study

First line trials

Current status

Recruiting

Study sponsor

Centre Léon Bérard

Scientific lead / contact

Franck-Emmanuel NICOLINI, MD
Centre Léon Bérard

Principal investigator

Franck-Emmanuel NICOLINI, MD
Centre Léon Bérard

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

France

CHU Amiens Picardie
Amiens, 80000
Principal Investigator: Amandine Charbonnier, MD

CHU d'Angers
Angers
Principal Investigator: Martine Gardemba-Pain, MD

Centre Hospitalier Annecy-Genevois
Annecy, 74000
Principal Investigator: Pascale Cony-Makhoul, MD

CH d'Avignon
Avignon, 84000
Principal Investigator: Hacène Zerazhi, MD

Chru Besançon
Besançon, France, 25000
Principal Investigator: Marion Simonet-Boissard, MD

Institut Bergonie
Bordeaux, 33000
Principal Investigator: Gabriel Etienne, MD

Institut D'Hematologie de Basse Normandie
Caen, 14000
Principal Investigator: Hyacinthe Atchroué Johnson-Ansah, MD

CHU D'Estaing
Clermont-Ferrand, 63000
Principal Investigator: Marc Berger, MD

Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91000
Principal Investigator: Bertrand Joly, MD

Hopital Henri Mondor
Créteil, 94000
Principal Investigator: Lydia Roy, MD

CHU de Grenoble
Grenoble, 38000
Principal Investigator: Stéphane Courby, MD

CH de Versailles - Hôpital André Mignot
Le Chesnay
Principal Investigator: Philippe Rousselot, MD

Hôpital Claude Huriez - CHRU de Lille
Lille
Principal Investigator: Valérie Coiteux, MD

CHU Limoges - Hôpital Dupuytren
Limoges
Principal Investigator: Pascal Turlure, MD

Centre Léon Bérard
Lyon, 69008
Principal Investigator: Franck-Emmanuel Nicolini, MD

Hopital Saint Eloi
Montpellier, 34000
Principal Investigator: Philippe Quittet, MD

Chu Hotel Dieu
Nantes, 44000
Principal Investigator: Viviane Dubruille, MD

CHU Nîmes Caremeau - Institut de Cancérologie du Gard
Nîmes
Principal Investigator: Eric Jourdan, MD

Hopital Saintantoine
Paris, 75000
Principal Investigator: Simona Lapusan, MD

CHU Poitiers
Poitiers
Principal Investigator: Emilie Cayssials, MD

CHU - Hopital de Pontchaillou
Rennes, 35000
Principal Investigator: Martine Escoffre-Barbe, MD

Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez
Principal Investigator: Denis Guyotat, MD

Institut de cancérologie Strasbourg Europe
Strasbourg, 67000
Principal Investigator: Shanti Natarajan-Ame, MD

Iuct Toulouse - Oncopole
Toulouse
Principal Investigator: Françoise Huguet, MD

CHRU Nancy/Brabois
Vandœuvre-lès-Nancy, 54500
Principal Investigator: Agnès Guerci-Bresler, MD

Hopital Paul Brousse
Villejuif, France, 94800
Principal Investigator: Laurence Legros, MD

 


 
   
 

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