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

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

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

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

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

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

The trial will be expanded to all SOKAL and ELTS (EUTOS long-term survival) patients if there no safety warnings after the first patients in 2020. Further sites will be opened in France and Switzerland. 


 
   
 

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