coiaward2010

DASTOP-2 (CA180-655) = Second treatment stop [Denmark, Finland, France, Germany, Sweden, Norway, The Netherlands]

Study title

DASTOP-2 = A multicenter trial where patients with CML stop medication a second time

Scientific title

Persistence of major molecular remission in chronic myeloid leukemia after a second stop of TKI treatment in patients who failed an initial stop attempt: A prospective multicenter study (EudraCT 2016-004106-34)

Indication and most important inclusion criteria

This study includes male or female patients who:

- are at least 18 years old
- have chronic myeloid leukemia (CML) in chronic phase (CP) with confirmed presence of the BCR/ABL1 gene
- who have had a molecular relapse after attempting to stop therapy with a tyrosine kinase inhibitor (TKI) within the EUROSKI study or outside the study but according to EUROSKI procedures. Patients who attempted stopping outside the study must have received a TKI for at least 3 years before the first stop, including dasatinib in this study during the last 2 years. Patients must have been in deep molecular response (MR4) for at least 1 year before stopping.
- who have been treated with any TKI for at least 1 year after having failed a first attempt to stop treatment with a TKI

Short description of intervention

The purpose of this study is to assess treatment-free remission (persistence of major molecular remission) after a second attempt to stop TKI treatment

Type of study

7. Treatment discontinuation trials

Current status

Recruiting

Study sponsor

Uppsala University Hospital, Sweden,
with financial support from BMS

Scientific lead / contact

Ulla Olsson-Strömberg, Uppsala University Hospital

Principal investigator

Ulla Olsson-Strömberg, Uppsala University Hospital

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Denmark

Aarhus
Aarhus University Hospital
Jesper Stentoft

Odense
Odense University Hospital
Andreja Dimitrijevic (National Coordinator)

Finland

Helsinki
Department of Hematology Helsinki University Hospital
Satu Mustjoki (National Coordinator) and Perttu Koskenvesa


France

Créteil
Centre Hospitale-Universitaire, Créteil
Lydia Roy (National Coordinator)

More centers are going to join in France later.


Germany

Bonn
Dominik Wolf (National Coordinator)

Essen
Joachim Göthert

Mannheim
Susanne Saußele

Marburg
Anderas Burchert

Villingen-Schwenningen
Paul Graf la Rosée


Norway

Bergen
Haukeland University Hospital
Bjørn Tore Gjertsen

Oslo
Oslo University Hospital
Tobias Gedde Dahl

Stavanger
Stavanger University Hospital
Waleed Majeed (National Coordinator)

Trondheim
St Olavs Hospital-Trondheim University Hospital
Henrik Hjorth Hansen


Sweden

Linköping
Linköping University Hospital
Kourosh Lofti and Arta Dreimane

Lund
Lund University Hospital
Johan Richter, Anna Lubking and Elena Holm

Örebro
Örebro University Hospital
Erik Ahlstrand

Stockholm
Karolinska Hospital
Leif Stenke and Lotta Ohm

Umeå
Umeå University Hospital
Berit Markevärn

Uppsala
Uppsala University Hospital (Akademiska)
Stina Söderlund, Ulla Olsson Strömberg (Principal Investigator)

The Netherlands


Amsterdam
Jeroen Janssen (National Coordinator)

Dordrecht
Peter Westerweel

Nijmegen
Nicole Blijlevens

Rotterdam
Peter Boekhorst

 


 
   
 

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