Traitement des syndromes myélodysplasiques par l'association aracytine et bortezomib

• Conditions: 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).

• Registration Number: EUCTR2005-005794-29-BE
• Lead Sponsor: Groupe français des Myélodysplasies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-06
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 39

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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)<br>- safety (WHO scoring for side effects)