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Brief Title: European Stop Tyrosine Kinase Inhibitor Study
Official Title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI
Study ID: NCT01596114
Brief Summary: The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy. Secondary goals include: * Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment) * Evaluation of quality of life (QoL) in patients stopping TKI * Evaluation of medico-economic impact of stopping TKI * Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log * Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P \> 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (\> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fakultní nemocnice, Brno, , Czechia
Fakultní nemocnice Hradec Králové, Hradec Kralove, , Czechia
University Hospital Olomouc, Olomouc, , Czechia
University Hospital Plzen, Plzen, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Prague, , Czechia
Ústav hematologie a krevní transfuze, Prague, , Czechia
Odense University Hospital, Odense, , Denmark
Helsinki University Central Hospital, Helsinki, , Finland
CHU d'Angers, Angers, , France
Institut Bergonié, Bordeaux, , France
Université Victor Segalen, Bordeaux, , France
Hôpital André Mignot, Chesnay cedex, , France
Chu Estaing, Clermont Ferrand, , France
Hôpital Claude Huriez, Lille, , France
Hôpital Édouard Herriot, Lyon, , France
Institut Paoli-Calmettes (IPC), Marseille, , France
Centre Hospitalier Universitaire (CHU) de Nantes, Nantes, , France
Hôpital de l'Archet, Nice, , France
Hôpital Saint-Louis, Paris cedex 10, , France
Hôpital Necker-Enfants Malades, Paris Cedex 15, , France
Hopital de la Milétrie, Centre Hospitalier Universitaire (CHU) de Poitiers, Poitiers, , France
Hôpital Pontchaillou, Rennes, , France
Hôpital Purpan, Toulouse, , France
CHU de Tours, Tours, , France
Hôpital de Brabois, Vandoeuvre-lès-Nancy, , France
Uniklinik RWTH, Aachen, , Germany
Universitätsklinikum, Bonn, , Germany
Klinikum, Chemnitz, , Germany
Universitätsklinikum, Jena, , Germany
Klinikum Kempten-Oberallgäu, Kempten, , Germany
Universitätsmedizin Mannheim, Universität Heidelberg, Mannheim, , Germany
Universitätsklinikum Giessen und Marburg GmbH, Marburg, , Germany
MVZ Klinikum Straubing GmbH, Straubing, , Germany
University of Athens, Society of Hematology, Athens, , Greece
VU Academic Medical Center, Amsterdam, , Netherlands
Albert Schweitzer Hospital, Dordrecht, , Netherlands
Oslo universitetssykehus HF Rikshospitalet, Oslo, , Norway
Stavanger University Hospital, Stavanger, , Norway
University Hospital of Northern Norway, Tromsø, , Norway
Norwegian University of Science and Technology, Trondheim, , Norway
Instituto Português de Oncologia Francisco Gentil, Lisboa, , Portugal
Karoliniska Univ hospital Huddinge, Huddinge, , Sweden
Univ hospital Linköping, Linköping, , Sweden
Sunderby hospital, Luleå, , Sweden
Lunds Universitet, Lund, , Sweden
Karoliniska Univ sjh Solna, Stockholm, , Sweden
Länssj Sundsvall, Sundsvall, , Sweden
Norrlands Univ hospital, Umeå, , Sweden
Uppsala University hospital, Uppsala, , Sweden
Univ hospital Örebro, Örebro, , Sweden
Name: Susanne Saussele, Prof. Dr.
Affiliation: Universitätsmedizin Mannheim, Universität Heidelberg
Role: PRINCIPAL_INVESTIGATOR