Myelodysplastic syndromes MedDRA version: 9.1 Level: HLT Classification code 10028536 Term: Myelodysplastic syndromes
Conditions
Interventions
Trade Name: Azacitidine (Vidaza®)
Product Name: Azacitidine (Vidaza®)
Pharmaceutical Form: Suspension for injection
Trade Name: NEORECORMON 30 000 U
Pharmaceutical Form: Solution for injection
Sponsors
Groupe Francophone des Myélodysplasies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MDS defined as •RCMD, RA with or without ring sideroblasts •RAEB 1, or CMML 1, if WBC 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Major erythroid response rate after 6 courses, assessed according to IWG 2000 criteria ;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 •Duration of erythroid response •Red blood cell transfusion independence at 4 and 6 months •Overall survival and time to IPSS progression •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. | — |
Countries
France
Outcome results
None listed