DACOTA = Decitabine with or without Hydroxyurea versus Hydroxyurea in CMML[Europe]
Study title
DACOTA = Phase III Trial of Decitabine with or without Hydroxyurea versus Hydroxyurea in CMML [Europe]
Scientific title
Randomized Phase III Study of Decitabine +/- Hydroxyurea (HY) Versus HY in Advanced Proliferative CMML (GFM-DAC-CMML) (EudraCT no. 2014-000200-10, ClinicalTrials.gov NCT02214407)
Type of study
Other haematological trials (non-CML)
Current status
No longer recruiting
What is the purpose of the study
Patients with advanced Chronic Myelomonocytic Leukemia (CMML) will be assigned to one of two study arms and will receive one of the following two treatments: either 20 mg/m2 decitabine intravenously for 5 days every 28 days with our without hydroxyurea or hydroxyurea alone at a dose of up to 4 g/day.
Treatment will be continued until an event is reached (death, transformation to acute myeloid leukemia (AML) or progression of meloproliferation (increase in myelocyte count))
Key inclusion criteria
This study enrolls patients aged 18 years and older with a CMML diagnosis according to WHO criteria and a white blood count of at least 13 G/L. Patients must also meet at least two further criteria, such as bone marrow blasts at least 5%, anemia or enlarged spleen. Patients must not have received any other treatment except for best best supportive care (BSC), erythropoiesis stimulating agents (ESAs) and short-term treatment with hydroxyurea.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)
Study sponsor
Groupe Francophone des Myelodysplasies (GFM), Paris
Scientific lead / contact
Pierre Fenaux
Principal investigator
Pierre Fenaux, Hopital St Louis T4, Paris
Study centers / principal investigators
France
Angers
CH Angers
Angers, 49 000
Bayonne
Centre Hospitalier de La Cote Basque
Bayonne, 64100
Bobigny
Hôpital Avicenne
Bobigny, 93009
Bordeaux Pessac
CHU de Haut-Lévèque
Bordeaux Pessac, 33604
Clermont-Ferrand
CHU de Clermont-Ferrand
Clermont-Ferrand, 63058
Creteil
Centre Henri Mondor
Creteil, 94010
Grenoble
Service d’Hématologie Clinique
CHU Albert Michallon,
Grenoble, 38043
Limoges
CHRU de Limoges
Limoges, 87046
Lyon
Centre Hospitalier Lyon Sud
Lyon, 69495
Marseille
Département d’hématologie
Institut Paoli-Calmette, Marseille, 13009
Nice
Hematology Dpt, CHU Archet
Nice, 06202
Paris
Hopital St Louis T4
Paris, 75475
Perpignan
Centre Hospitalier Joffre
Perpignan, 66046
Rouen
Centre Henri Bequerel
Rouen, 76038
Toulouse
Hopital Purpan Service d’Hématologie Clinique
Toulouse
Germany
Berlin
Charité-Universitätsmedizin Berlin
Campus Benjamin Franklin
Medizinische Klinik III / Hämatologie, Onkologie und Transfusionsmedizin
Chemnitz
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III
Dresden
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Medizinische Klinik I
Düsseldorf
Marien Hospital Düsseldorf GmbH
Akademisches Lehrkrankenhaus der Universität Düsseldorf
Innere Medizin und Hämatologie
Düsseldorf
Klinik für Hämatologie, Onkologie und klinische Immunologie
Heinrich Heine Universität Düsseldorf
Freiburg
Universitätsklinikum Freiburg
Klinik für Innere Medizin I
Hämatologie, Onkologie und Stammzelltransplantation
Hamburg
Asklepios Klinik St. Georg
Abteilung Hämatologie, Onkologie und Stammzelltransplantation
Hannover
Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Medizinische Hochschule Hannover
Mannheim
Universitätsklinikum Mannheim Medizinische
Klinik III Hämatologie und Internistische Onkologie
München
Technische Universität München
Klinikum Rechts der Isar
III. Medizinische Klinik
Potsdam
Medizinisches Versorgungszentrum für Blut- und Krebserkrankungen
Tübingen
Universität Tübingen
Medizinische Klinik Hämatologie/Onkologie/Pulmologie
Winnenden
Onkologie und Palliativmedizin
Rems-Murr-Klinik Waiblingen