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 (ClinicalTrials.gov NCT03573596; EudraCT 2016-004106-34, )
Type of study
Treatment discontinuation trials
Current status
No longer recruiting
What is the purpose of the study
The purpose of this study is to assess treatment-free remission (persistence of major molecular remission) after a second attempt to stop TKI treatment
Key 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
Key exclusion criteria
Where can I find additional information
Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
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
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
Lino Teichmann
Essen
Joachim Göthert
Mannheim
Susanne Saußele (National Coordinator)
Norway
Bergen
Haukeland University Hospital
Bjørn Tore Gjertsen
Oslo
Oslo University Hospital
Tobias Gedde Dahl
Stavanger
Stavanger University Hospital
Waleed Majeed (National Coordinator)
Tromsø
Tromsø University Hospital
Anders Vik
Trondheim
St Olavs Hospital-Trondheim University Hospital
Henrik Hjorth Hansen
Sweden
Linköping
Linköping University Hospital
Kourosh Lofti and Arta Dreimane
Luleå
Sunderby Sjukhus
Anneli Enblom-Larsson
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