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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01186939
First received: August 20, 2010
Last updated: April 2, 2012
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Myelodysplastic Syndromes
Drug: Azacitidine
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period [ Time Frame: 43- 68 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: April 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azacitidine
Azacitidine (study drug) plus best supportive care.
Drug: Azacitidine
Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
Other Name: AZA

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186939

Locations
Australia, Victoria
East Melbourne, Victoria, Australia
Australia
Herston, Australia
Perth, Australia
Woolloongabba, Australia
Bulgaria
Plovdiv, Bulgaria
France
Aulnay Sous Bois Cedex, France
Germany
Berlin, Germany
Dusseldorf, Germany
Essen, Germany
Kiel, Germany
Greece
Heraklio, Crete, Greece
Haidari, Greece
Hungary
Budapest, Hungary
Italy
Bologna, Italy
Firenze, Italy
Genova, Italy
Rome, Italy
Netherlands
Nijmegen, Netherlands
Poland
Lodz, Poland
Spain
Avda Campanar, Spain
Leon, Spain
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Celgene Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01186939     History of Changes
Other Study ID Numbers: AZA PH GL 2003 CL 001 E
Study First Received: August 20, 2010
Results First Received: August 26, 2010
Last Updated: April 2, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Italy: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Bulgaria: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
France: Ministry of Health
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Netherlands: Ministry of Health, Welfare and Sport
Greece: Ministry of Health and Welfare
Spain: Ministry of Health

Keywords provided by Celgene Corporation:
Myelodysplastic Syndromes
MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 23, 2014