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OPTIM DASATINIB (Optimized Tyrosine Kinase Inhibitors Monotherapy)
Sponsor: Versailles Hospital
Summary
This protocol is a multicentric interventional phase II study from the French CML Intergroup (FILMC). The core of the protocol is to explore the efficacy and safety of an optimization strategy consisting in the modulation of the dasatinib daily dose according to the results of repeated plasmatic levels of dasatinib. The objective of this strategy is to improve the overall results of the treatment of early CP-CML in order to avoid the development of resistance and BCR-ABL tyrosine kinase mutations. The study will be conducted in selected FILMC and Canadian centers. The study is sponsored by the Hôpitaux de Versailles and supported by Bristol-Myers Squibb. The dasatinib treatment will be provided by Bristol-Myers Squibb until marketing authorization is granted in that indication.
Official title: A PROSPECTIVE RANDOMIZED PHASE II STUDY EVALUATING THE OPTIMIZATION OF THE RESIDUAL PLASMATIC LEVEL OF DASATINIB (SPRYCEL®) IN PATIENTS NEWLY DIAGNOSED WITH CHRONIC PHASE CHRONIC MYELOGENOUS LEUKAEMIA (CP-CML).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
289
Start Date
2009-05
Completion Date
2013-12
Last Updated
2026-07-06
Healthy Volunteers
No
Interventions
Dasatinib
Dasatinib is a multitargeted tyrosine kinase inhibitor with a 300-fold more potent activity on the BCR-ABL tyrosine kinase in vitro compared to imatinib mesylate
Locations (34)
Southern Alberta Cancer Research Institute
Calgary, Canada
Hôpital Charles LeMoyne
Greenfield Park, Canada
Queen elisabeth II Health Sciences Center
Halifax, Canada
CH Pierre LeGardeur
Lachenaie, Canada
Moncton City Hospital
Moncton, Canada
Hôpital Général Juif - Sir. Mortimer B. Davis
Montreal, Canada
Hôpital Maisonneuve-Rosemont
Montreal, Canada
Hôpital Royal Victoria
Montreal, Canada
Hôpital de l'Enfant Jésus - Centre hospitalier affilié universitaire de Québec
Québec, Canada
Pavillon Hôtel-Dieu de Québec - Centre hospitalier universitaire de Québec
Québec, Canada
CHU Angers
Angers, France
Hôpital Avicenne
Bobigny, France
Institut Bergonie
Bordeaux, France
Hopital MORVAN
Brest, France
CH René Dubos
Cergy-Pontoise, France
Hôpital d'Instruction de Armées Percy
Clamart, France
Hopital Henri MONDOR
Créteil, France
Hôpital Claude Huriez
Lille, France
CH Lyon Sud
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Hôpital d'Annecy
Metz-Tessy, France
C.H.U. Brabois
Nancy, France
CHU Hoptel dieu
Nantes, France
Hôpital l'Archet 1
Nice, France
CHU Caremeau
Nîmes, France
Hopital Saint Louis
Paris, France
Hôpital Necker-Enfants Malades
Paris, France
Hôpital St Antoine
Paris, France
CHU Poitiers
Poitiers, France
CHU Rennes - Pontchaillou
Rennes, France
Centre René Huguenin
Saint-Cloud, France
Hôpital Purpan
Toulouse, France
CHRU Bretonneau
Tours, France
Central Hospital
Versailles, France