A phase II Study of Azacitidine (Vidaza®) combined to Epoetin beta (NeoRecormon®) in IPSS low-risk and intermediate-1 MDS Patients, resistant to ESA - GFM-Aza-Epo-2008-01

Conditions: Myelodysplastic syndromes
MedDRA version: 9.1Level: HLTClassification code 10028536Term: Myelodysplastic syndromes

Registration Number: EUCTR2008-004541-29-FR

Lead Sponsor: Groupe Francophone des Myélodysplasies

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

MDS defined as
•RCMD, RA with or without ring sideroblasts
•RAEB 1, or CMML 1, if WBC < 13 G /l according to the WHO classification (see appendix 1)
•with a low or int-1 IPSS score
AND
•primary or secondary resistance to epoetin alpha/ beta (> 60000 U/w) or darbepoetin (> 300ug/w), administered for at least 12 weeks
•requirement of RBC transfusions > 4 U in the previous 8 weeks
•Aged 18 years or more
•Adequate contraception, if relevant
•Negative pregnancy test if relevant
•Written Informed consent
•Ability to participate to a clinical trial and adhere to study procedures
•Health insurance
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

•Therapy related MDS (after chemo- or radiotherapy for a previous neoplasm or immune disorder)
•Patients with a planned allogeneic bone marrow transplantation
•Creatininemia >1.5 upper normal value or estimated Ccr less than 30ml/mn
•ALAT and ASAT >2.5 upper normal value
•Bilirubin >2N, except unconjugated hyperbilirubinemia due to dyserythropoiesis
•Heart failure NYHA > II
•Known allergy to mannitol
•Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
•ECOG > 2
•Life expectancy less than 3 months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Major erythroid response rate after 6 courses, assessed according to IWG 2000 criteria<br>;Secondary Objective: •% of major HI-E and minor HI-E after 4 and 6 courses according to IWG 2000 and HI-E IWG 2006 criteria<br>•Duration of erythroid response <br>•Red blood cell transfusion independence at 4 and 6 months<br>•Overall survival and time to IPSS progression<br>•Toxicity (NCI-CTAE);Primary end point(s): The evaluation of the efficacy will be achieved by the erythroid response rate (major versus minor and major plus minor versus failure) according the IWG 2000 and IWG 2006 response rate criteria (detailed in appendix 1) at 4 and 6 months of therapy.<br><br>

Secondary Outcome Measures