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Spots Global Cancer Trial Database for European Stop Tyrosine Kinase Inhibitor Study

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Susanne Saussele, Prof. Dr.

Affiliation: Universitätsmedizin Mannheim, Universität Heidelberg

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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