Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01186939




Registration number
NCT01186939
Ethics application status
Date submitted
20/08/2010
Date registered
23/08/2010
Date last updated
14/11/2019

Titles & IDs
Public title
An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)
Scientific 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)
Secondary ID [1] 0 0
AZA PH GL 2003 CL001 E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelodysplastic Syndromes 0 0
Condition category
Condition code
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Azacitidine

Experimental: Azacitidine - Azacitidine (study drug) plus best supportive care.


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants in Different Categories of Treatment Emergent Adverse Events for the Extension Period
Timepoint [1] 0 0
43- 68 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- East Melbourne
Recruitment hospital [2] 0 0
- Herston
Recruitment hospital [3] 0 0
- Perth
Recruitment hospital [4] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- East Melbourne
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Plovdiv
Country [2] 0 0
France
State/province [2] 0 0
Aulnay Sous Bois Cedex
Country [3] 0 0
Germany
State/province [3] 0 0
Berlin
Country [4] 0 0
Germany
State/province [4] 0 0
Dusseldorf
Country [5] 0 0
Germany
State/province [5] 0 0
Essen
Country [6] 0 0
Germany
State/province [6] 0 0
Kiel
Country [7] 0 0
Greece
State/province [7] 0 0
Crete
Country [8] 0 0
Greece
State/province [8] 0 0
Haidari
Country [9] 0 0
Hungary
State/province [9] 0 0
Budapest
Country [10] 0 0
Italy
State/province [10] 0 0
Bologna
Country [11] 0 0
Italy
State/province [11] 0 0
Firenze
Country [12] 0 0
Italy
State/province [12] 0 0
Genova
Country [13] 0 0
Italy
State/province [13] 0 0
Rome
Country [14] 0 0
Netherlands
State/province [14] 0 0
Nijmegen
Country [15] 0 0
Poland
State/province [15] 0 0
Lodz
Country [16] 0 0
Spain
State/province [16] 0 0
Avda Campanar
Country [17] 0 0
Spain
State/province [17] 0 0
Leon
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Silverman LR, Fenaux P, Mufti GJ, Santini V, Hells... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT01186939