Myelodysplastic syndrome (MDS) is a clonal disease of the bone marrow stem cells. The disease is frequently associated with cytopenia and/or blastosis. An evolution to an acute leukemia is not unfrequent (~ 30%). Treatments are very disapointing especially for high risk MDS. The prognosis mainly depends on blastosis, cytopenia and cytogenetic abnormalities but the disease is typically uncurable (except BMT).
Conditions
Interventions
Trade Name: Cytosar
Product Name: Aracytine
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: cytarabine
Concentration unit: mg/m2 milligram(s)/square meter
Conce
Sponsors
Groupe français des Myélodysplasies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - written informed consent - more than 18y - MDS with score IPSS Int-2 or high - life expectancy > 6 months - no other available treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - lung, heart, neurologic, gastrointestinal or genito-urinary impaired condition - intensive chemotherapy during 3 last months - more than 30% blast cells in bone marrow - ECOG 3 or 4 - clinically relevant peripheral neuropathy - life expectancy < 6 months - CMML - pregnant or breast feeding patient - creatinin clearance < 30 ml/min
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: evaluate the efficiency (CR, PR) of the association cytarabine - bortezomib in high-risk MDS. ;Secondary Objective: evaluation of the safety of the association in this type of patients evaluation of the effect of the association on the transfusion frequency;Primary end point(s): - hematological response (CR, PR, PD, and hématologic improvement ) following IWG criteria (16 th week) - safety (WHO scoring for side effects) | — |
Countries
Belgium
Outcome results
None listed