Azacytidine for the Treatment of Myelodysplastic Syndromes/Acute Myeloid Leukemia (MDS/AML) With High Risk (Chromosome 7 and or Complex) Cytogenetic Abnormalities
NCT00915785 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2013-04-24
Summary
The purpose of this study is to assess the hematological and cytogenetic responses with 5 azacytidine in patients over 55 years of age with MDS/AML due to chromosome 7 abnormalities and to assess the hematological and cytogenetic response rates in patients with relapsed AML and chromosome 7 abnormality.
Conditions
- Myelodysplastic Syndromes
- Leukemia, Myeloid, Acute
Interventions
- DRUG
-
5 azacytidine
Patients will receive azacytidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they are discontinued from the treatment.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Ghulam J Mufti, MB, DM, FRCP, FRCPath · King's College London
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-11-30
- Primary Completion
- 2013-04-30
Countries
- United Kingdom
Study Locations
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