Clinical Trials. gov identifier:
NCT02214407
Study code:
GFM-DAC-CMML
N° of patients expected by the study in Italy:
48
Study status:
Enrollment ongoing
Età:
> 18 years old
Myelodysplasia object of the study:
CMML ( Chronic MyeloMonocytic Leucemia)
Multicentric phase III study
Title of the study:
A RANDOMIZED PHASE III STUDY OF DECITABINE WITH OR WITHOUT HYDROXYUREA VERSUS HYDROXYUREA IN PATIENTS WITH ADVANCED PROLIFERATIVE CHRONIC MYELOMONOCYTIC LEUKEMIA
Description of the study:
CMML is the most frequent entity among myelodysplastic / myeloproliferative syndromes, CMML is a rare chronic leukemia usually observed in older subjects (mean age 70 years). It is a clonal disease of the bone marrow characterized by persistant monocytosis.
As in MDS, allogeneic stem cell transplantation (ASCT), although it remains today the only curative option is rarely feasible in CMML due to the older age of patients The mainstay of CMML treatment remains hydroxyurea, in recent years, however,has been studied the use of Decitabine as a hypomethylating agent. The primary objective of the study is to compare the two therapies in terms of Event free Survival
This is an interventional randomized multicentric phase III study involving the Groupe Francophone des Myélodysplasies (GFM), del German group and FISM.
The Sponsor of the study is GFM, FISM is delegate sponsor in italy.
The study provides the enrollment of 168 patients in total and for Italy are planned 48 patients.
There are 2 arms of randomization:
- Decitabina
- Idrossiurea
Randomization (1:1) will be stratified according to the two following criteria:
- WHO category of CMML
- Severe anemia
- Country of including center
The study provides the shipment of sending biological samples to a central laboratory in France and the centralized morphological review of diagnosis.