Clinical trial NCT01186939: An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)
Official title: AZA PH GL 2003 CL 001 - Extension A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndromes
MDS
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2010-08-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period
timeFrame: 43- 68 months
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
state: Victoria
city: Herston
country: Australia
city: Perth
country: Australia
city: Woolloongabba
country: Australia
city: Plovdiv
country: Bulgaria
city: Aulnay Sous Bois Cedex
country: France
city: Berlin
country: Germany
city: Dusseldorf
country: Germany
city: Essen
country: Germany
city: Kiel
country: Germany
city: Heraklio
country: Greece
state: Crete
city: Haidari
country: Greece
city: Budapest
country: Hungary
city: Bologna
country: Italy
city: Firenze
country: Italy
city: Genova
country: Italy
city: Rome
country: Italy
city: Nijmegen
country: Netherlands
city: Lodz
country: Poland
city: Avda Campanar
country: Spain
city: Leon
country: Spain
city: London
country: United Kingdom
Study officials:
References:
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