Pilot study of 5 Azacitidine in the treatment of MDS/AML with high risk (chromosome 7 and/or complex cytogenetic abnormality) - Azacitidine for MDS with high risk cytogenetics
Phase 1
Active, not recruiting
- Conditions
- myelodysplastic syndromes/relapsed Acute myeloid leukaemia
- Registration Number
- EUCTR2005-003732-22-GB
- Lead Sponsor
- Kings College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 43
Inclusion Criteria
Chromosome 7 or complex cytogenetic abnormality in MDS/AML
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
Allergy to drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess complete/cytogenetic remission in patients with chromosome 7 abnormalities ;Secondary Objective: Assess duration of response;Primary end point(s): Complete remission
- Secondary Outcome Measures
Name Time Method