An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)

Phase 3

Completed

• Conditions: Myelodysplastic Syndromes
• Interventions: Drug: Azacitidine

• Registration Number: NCT01186939
• Lead Sponsor: Celgene

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 commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.

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 commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.

During the extension phase, participants were treated based on 28-day cycles and monitored for hematologic, nonhematologic, and renal toxicities. Recommended monitoring procedures included complete blood count with differential and platelets at least once each cycle prior to dosing and as needed, bone marrow biopsy and aspirate as clinically indicated, and additional tests or more frequent monitoring at the investigator's discretion based on the patient's clinical status. The azacitidine dose could be modified for toxicities. Laboratory data were not collected during the extension phase.

Study Timeline

• Study Start: 2007-04-01
• Primary Completion: 2009-09-01
• Study Completion: 2009-09-01
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Results First Submitted: 2010-08-26
• Results First Submitted QC: 2010-08-26
• Results First Posted: 2010-09-21
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azacitidine	Azacitidine	Azacitidine (study drug) plus best supportive care.

Primary Outcome Measures

Name	Time	Method
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period	43- 68 months	Participant counts for a variety of subsets of treatment emergent adverse events (TEAEs)during the extension study period (43-68 months). Subsets include participants counts for serious TEAEs, serious TEAEs that the investigator evaluated as releated to treatment, TEAEs leading to discontinuation of therapy, or a dose reduction, or a dose interruption.