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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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-003732-22-GB
Enrollment
40
Registered
2005-09-05
Start date
2005-10-03
Completion date
Unknown
Last updated
2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myelodysplastic syndromes/relapsed Acute myeloid leukaemia

Interventions

Trade Name: Vidaza Product Name: Azacitidine Product Code: Azacitidine Pharmaceutical Form: Powder for injection* INN or Proposed INN: A

Sponsors

Kings College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Allergy to drug

Design outcomes

Primary

MeasureTime frame
Main Objective: Assess complete/cytogenetic remission in patients with chromosome 7 abnormalities ;Secondary Objective: Assess duration of response;Primary end point(s): Complete remission

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026