DasaHIT = Dasatinib Holiday for Improved Tolerability [Germany]

Study title

DasaHIT = Dasatinib Holiday for Improved Tolerability

Scientific title

Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naive disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors (2nd line) (EudraCT 2015-003502-16)

Indication and most important inclusion criteria

This study includes patients aged 18 years and above who have been newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemie (CML) in any phase or who have failed treatment or are intolerant to previous treatment with other tyrosine kinase inhibitors (TKI) (imatinib, nilotinib, bosutinib, ponatinib). To be included patients must also have a score of at least 2 on the ECOG performance scale assessing the quality of life of cancer patients.

Patients with Ph-negative CML or socalled variant translocations, who are BCR-ABL-positive, are also considered eligible for inclusion.

Short description of intervention

This study will investigate whether treatment with dasatinib over two years is equally effective when dasatinib is not given on weekends (treatment pause) compared to daily administration of dasatinib without treatment pauses.

Type of study

Therapy optimization trial

Current status

recruiting

Study sponsor

Friedrich-Schiller-Universität Jena, Germany, with financial support from Bristol-Myers Squibb

Scientific lead / contact

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
Germany

Principal investigator

Prof. A. Hochhaus
Klinik und Poliklinik für Innere Medizin II
Universitätsklinikum Jena
Germany

Additional information

Short protocol

Study centers / principal investigators

Germany

Gesundheitszentrum St. Marien GmbH
Amberg

Studienzentrum Aschaffenburg
Aschaffenburg

Universitätsklinikum Bonn
Bonn

Klinikum Bremen Mitte
Bremen

Klinikum Chemnitz
Chemnitz

Gemeinschaftspraxis Mohm
Dresden

Universitätsklinikum Carl Gustav Carus
Dresden

Universitätsklinikum Essen
Essen

Klinikum Goch
Goch

Hämato-Onkologische Gemeinschaftspraxis Halberstadt
Halberstadt

MediProjekt GbR Hannover
Hannover

Universitätsklinikum Jena
Jena

Onkolog. Schwerpunktpraxis, Dres. Richard Hansen, Susanne Pfitzner-Dempfle, Manfred Reeb
Kaiserslautern

Städt. Klinikum Karlsruhe
Karlsruhe

Städtisches Krankenhaus Kiel
Kiel

Universitätsklinikum SH
Kiel

Universität Leipzig
Leipzig

Universitätsmedizin Mannheim
Mannheim

Schick Hämatologisch-Onkologische Praxisgemeinschaft
München

Medizinische Klinik A (Hämatologie, Hämostaseologie, Onkologie und Pneumologie)
Münster

Stauferklinikum Schwäbisch Gmünd
Mutlangen

Klinikum Passau
Passau

Kreisklinikum Reutlingen
Reutlingen

Klinikum Südstadt Rostock
Rostock

Universitätsklinikum Ulm
Ulm

Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen