EUROSKI (EUROStopKinaseInhibitor)

Study title

EUROSKI (EUROStopKinaseInhibitor) = Stopping TKI in patients with CML in complete molecular remission (MR4)

Scientific title

Multicenter prospective trial estimating the persistence of molecular remission in chronic myeloid leukemia after stopping TKI (EUDRACT 2011-000440-22, ClinicalTrials.gov NCT01596114)

Indication and most important inclusion criteria

Chronic myeloid leukemia (CML) in CP on treatment with any TKI in first line or in second line because of toxicity to first line TKI or with TKI in combination

Potential participants of the study should have been treated with TKIs for at least 3 years and should have been in MR4 (less than 0,01% BCR-ABL IS) for at least one year.

At least complete molecular remission MR4 (either (i) detectable disease <=0.01% BCR-ABL IS or (ii) undetectable disease in cDNA with >=10,000 ABL or >=24,000 GUS transcripts) for at least one year; at least three PCR-results with MR4 within the last year (±2 months) before study entry and no PCR-results >0.01% during the same period.
Before inclusion confirmation of MR4 through a EUTOS-CMR laboratory.
Baseline data and documentation on treatment before study entry available.
Known baseline data at diagnosis, EURO-Score

Patients with previous or planned allogeneic stem cell transplantation will be excluded.

Short description of intervention

Stopping TKI in patients with CML in complete molecular remission (MR4)

Type of study

Treatment discontinuation trial

Current status

Recruitment completed

Study sponsor

European LeukemiaNet

Scientific lead / contact

Saussele, Dr. med. Susanne
Universitätsklinikum Mannheim, Germany

Principal investigator

Mahon, Prof. Dr. François-Xavier
CHU de Bordeaux, France

Additional information

Short protocol in European LeukemiaNet
Study description in US register ClinicalTrials.gov, a service of the U.S. National Institutes of Health

Study centers / principal investigators

Czech Republic

Brno
Masaryk University and University Hospital Brno
Dpt. of Internal Medicine, Hematology and Oncology
Prof. Jiri Mayer

Hradec Králové,
University Hospital Hradec Králové
(Fakultni nemocnice HradeKrélové)
4th Department of Internal Medicine - Hematology
Dr. Jaroslava Voglová

Prague
Institute of Hematology and Blood Transfusion, (Ustav hematologie a krevni transfuze)
Prof. Hana Klamova

The Royal Vinohrady Teaching Hospital (Fakultni nemocnice Kralovske Vinohrady)
Dpt. of Internal Medicine and Hematology
Dr. Olga Cerna

Plzen
University Hospital Plzen
Dpt. of Hematology and Oncology
Dr. Michal Karas

Olomouc
University Hospital Olomouc
Dpt. of Hematology and Oncology
Dr. Edgar Faber

Finland

Helsinki
Helsinki University Central Hospital Division of Haematology
Department of Medicine
Prof. Kimmo Porkka

 

France

Angers
CHU d'Angers
Service des Maladies du Sang
Dr. Martine Gardembas-Pain

Bordeaux
Centre Hospitalier Universitaire (CHU) de Bordeaux
Hôpital Haut Lévèque
Pessac
Prof. François-Xavier Mahon

Bordeaux Bergonie
Institut Bergonié
Dr. Gabriel Etienne

Clermont Ferrand
CHU ESTAING
Prof. Marc Berger

Le Chesnay
Hôpital André Mignot,
Service d'Hématologie et d'Oncologie
Prof. Philippe Rousselot

Lille
Universitaire Regional (CHRU) de Lille
Centre Hospitalier
Hôpital Claude Huriez
Dr. Valérie Coiteux

Lyon
Centre Hospitalier Universitaire des Hospices Civils de Lyon (CHU des HCL)
Hôpital Edouard Herriot
Dr. Franck Nicolini

Marseilles
Centre de Lutte Contre le Cancer (CLCC) de Marseille
Institut Paoli-Calmettes (IPC)
Dr. Aude Charbonnier

Nantes
Centre Hospitalier Universitaire (CHU) de Nantes
Hôpital Hôtel-Dieu,
Prof. Viviane Dubruille

Nice
Centre Hospitalier Universitaire (CHU) de Nice
Hôpital de l'Archet
Dr. Laurence Legros

Paris 10
Hôpital Saint-Louis
Dr. Delphine Rea

Paris 15
Hôpital Necker-Enfants Malades
Service Hématologie
Prof. Bruno Varet

Poitiers
Centre Hospitalier Universitaire (CHU) de Poitiers
Hopital de la Milétrie
Prof. François Guilhot

Rennes
Hôpital Pontchaillou
Dr. Martine Escoffre.Barbe

Toulouse
Centre Hospitalier Universitaire (CHU) de Toulouse
Hôpital Purpan
Dr. FrançoiseRigal-Huguet

Tours
CHU de Tours
Dr. Emmanuel Gyan

Vandoeuvre les Nancy
Centre Hospitalier Universitaire (CHU) de Nancy
Hôpital de Brabois
Dr. Agnès-Paule Guerci

 

Germany

Aachen
Universitätsklinikum der RWTH Aachen
Medizinische Klinik IV
Prof. Dr. med. Tim Henrik Brümmendor

Bayreuth
Klinikum Bayreuth GmbH
Medizinische Klinik IV
PD Dr. med. Alexander Kiani

Bonn
Rheinische Friedrich-Wilhelms-Universität Bonn
Medizinische Klinik III
Dr. med. Viktor Janzen

Chemnitz
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III
Dr. med. Regina Herbst

Dresden
Gemeinschaftspraxis für Hämatologie und Onkologie
PD Dr. med. T. Illmer

Freiburg
Universitätsklinikum Freiburg
Abt. Innere Medizin I
Dr. med. Cornelius Waller

Hamburg
Universitätsklinikum Hamburg-Eppendorf

Heilbronn
Schwerpunktpraxis Onkologie
Dr. med. Jolanta Dengler

Jena
Universitätsklinikum Jena
Klinik und Poliklinik für Innere Medizin II
Hämatologie/Onkologie/Stammzelltransplantation
Prof. Dr. med. Andreas Hochhaus

Kempten
Klinikum Kempten-Oberallgäu gGmbH
Hämatologie, Onkologie und Palliativmedizin
Dr. med. Stefan Hanzel

Leer
Onkologische Schwerpunktpraxis
Dr. med. Carsten Janssen

Mannheim
Universitätsklinikum Mannheim
III. Medizinische Klinik
PD Dr. med. Susanne Saussele

Marburg
Klinikum der Philipps-Universität Marburg
Klinik für Hämatologie/Onkologie/Immunologie
Prof. Dr. med. Andreas Burchert

Munich
Klinikum rechts der Isar der
Technischen Unversität München

Oldenburg
Klinikum Oldenburg
Klinik für Onkologie und Hämatologie
Prof. Dr. med. Doris Kraemer

Straubing
MVZ Klinikum Straubing GmbH
Dr. med. Gernot Freunek

Wendlingen
Onkologische Schwerpunktpraxis
Dr. med. Robert Eckert

Würzburg
Universitätsklinikum Würzburg
Hämatologie/ Onkologie
Dr. Goebeler

 

Greece

Athens
Laikon General Hospital
Propaedeutic University of Athens - School of Medicine
Prof. Panayiotis Panayiotidis

 

Netherlands, The

Amsterdam
VU medisch centrum, secr. Hematologie
Prof. Gert Ossenkoppele

Norway

Oslo
Mr. Tobias Gedde-Dahl

Stavanger
Stavanger University Hospital
Department of Hematology and Oncology,
Dr. Majeed Waleed

Tromsø
University Hospital of Northern Norway
Department of Hematology
Prof. Franz Gruber

Trondheim
Department of Cancer, Research and Molecular Medicine
Prof. Henrik Hjorth-Hansen

 

Portugal

Lisbon
Instituto Portugues de Oncologia Francisco Gentil de Lisboa
Hematology
Dr. Antonio Almeida

 

Sweden

Linköping
Univ hospital Linköping
Haematology Centre
Dr. Kourosh Lotfi

Luleå
Sunderby hospital
Dept of Medicine
Dr. Kristina Myhr-Eriksson

Lund
Skåne University hospital
Haematology Centre
Prof. Johan Richter

Örebro
Univ hospital Örebro
Haematology Centre
Dr. Mats Björeman

Stockholm, Huddinge
Karolinska Univ hospital Huddinge
Haematology Centre
Dr. Sören Lehmann

Stockholm, Karolinska
Karoliniska Univ sjh Solna
Haematology Centre
Dr. Leif Stenke

Sundsvall
Länssj Sundsvall
Dept of Medicine
Dr. Anders Själander

Umeå
Haematology Centre
Norrlands Univ hospital
Dr. Berit Markevärn

Uppsala
Uppsala University hospital
Hematology section
Dr. Ulla Olsson-Strömberg