Myelodysplastic syndromes MedDRA version: 12.1 Level: LLT Classification code 10028533 Term: Myelodysplastic syndrome
Conditions
Interventions
Trade Name: Azacitidine (Vidaza®)
Product Name: Azacitidine (Vidaza®)
Pharmaceutical Form: Suspension for injection
Sponsors
Groupe Francophone des Myélodysplasies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • MDS defined according to WHO classification (also including RAEB-T according to FAB classification)(see appendix 1) with an intermediate-2 or high risk MDS IPSS score (see appendix 1). • Age = 18 years and 3.0 x upper limit of normal (ULN). • Serum total bilirubin > 1.5 mg/dL. (except for unconjugated hyperbilirubinemia due to Gilbert’s disease or secondary to MDS-related dyserythropoiesis). • 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: Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C • Pregnant and lactating patients are excluded because the effects of azacitidine on a foetus or breast-fed child are unknown • Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA > II), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. • Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy in the last 8 weeks. • Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities of an intensified regimen of azacitidine. • Less than 6 months since prior allogeneic stem cell transplantation. • Less than 3 months since prior autologous stem cell transplantation. • Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for = 3 years. • Prior treatment with azacitidine. • Known allergy/intolerance to azacitidine or mannitol. • ECOG > 2. • Life expectancy less than 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response rate (including CR and PR) according to IWG 2006 criteria for MDS after 4 and 8 cycles 75mg/m2/d azacitidine administered every 2 weeks.;Secondary Objective: - Safety/toxicity profil of azacitidine administered every 14 days (NCI-CTAE) - Responses (CR, PR, marrow CR, HI) according to IWG 2006 criteria and their duration - Overall survival and progression (IPSS/AML) free survival ;Primary end point(s): Primary endpoint of the trial will be to assess the response rate according to IWG 2006 criteria for MDS | — |
Countries
France
Outcome results
None listed