Clinical Trials. gov identifier:
Study code:
FISM-hMDS
N° of patients expected by the study:
32
Study status:
Enrollment ongoing
Age:
> 18 years old
Myelodysplasia object of the study:
Hypocellular Myelodysplastic Syndromes
Multicentric phase II study
Title of the study:
STUDY OF NATURAL KILLER CELLS IN PATIENTS WITH HYPOCELLULAR MYELODYSPLASTIC SYNDROME
Description of the study:
Description of the study:
Hypocellular myelodysplasia (hMDS) represent a fraction of myelodysplastic syndromes (about 15% of patients with MDS) and are characterized by an important role of autoimmune mechanisms in their pathogenesis.
There are some data that indicate how in patients with MDS there is correlation between NK activity – natural killer- (which falls) and evolution of the dysplastic situation (in progression), however, the role has not yet been defined , nor how these cells are actually involved in the evolution of the dysplastic clone.
Based on these assumptions, the aim of this project is to study the representation of NK cells in the marrow and peripheral blood of patients with hMDS (hypocellular myelodysplasia).
This is a observational multicentric phase II study; the Sponsor is FISM.
Can be enrolled patients with hypocellular myelodysplastic syndrome and low or intermediate 1 IPSS .
For this study it’s necessary to send samples of peripheral blood and bone marrow at diagnosis.