Status:
COMPLETED
An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)
Lead Sponsor:
Celgene
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became c...
Detailed Description
At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became c...
Eligibility Criteria
Inclusion
- Participants were considered eligible if they had been randomized to azacitidine treatment in the primary study and were receiving azacitidine at the time of study closure, had completed 12 months of treatment and observation in the primary study, and had signed the informed consent document for the extension phase of the study.
- See study: AZA PH GL 2003 CL 001 for a list of inclusion criteria for the primary study.
Exclusion
- None specific to the extension phase of the study
- See study: AZA PH GL 2003 CL 001 for a list of exclusion criteria for the primary study.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01186939
Start Date
April 1 2007
End Date
September 1 2009
Last Update
November 14 2019
Active Locations (22)
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1
East Melbourne, Victoria, Australia
2
Herston, Australia
3
Perth, Australia
4
Woolloongabba, Australia