EUCTR2008-004541-29-FRActive, not recruitingNot 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
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •Life expectancy less than 3 months
Investigators
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