GFM-DAC-CMML

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.