EUCTR2008-004541-29-FR
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myelodysplastic syndromes
- Sponsor
- Groupe Francophone des Myélodysplasies
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
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
- •Life expectancy less than 3 months
Outcomes
Primary Outcomes
Not specified
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