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)

Indication and most important 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.

Short description of intervention

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))

Type of study

Other haematological trials (non-CML)

Current status

recruiting

Study sponsor

Groupe Francophone des Myelodysplasies (GFM), Paris

Scientific lead / contact

Pierre Fenaux

Principal investigator

Pierre Fenaux, Hopital St Louis T4, Paris

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 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