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

What is the purpose of the study

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.

Key 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 3 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.

Key exclusion criteria

Estimated primary completion date

Where can I find 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: Anne Parry, 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

Chru Brest
Brest
Contact: Jean-Christophe IANOTTO, 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: José Miguel Torregrosa-Diaz, 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