Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071799
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2003-10-31
Brief Title:
A Survival Study in Patients With High Risk Myelodysplastic Syndromes Comparing Azacitidine Versus Conventional Care
Sponsor:
Celgene
Organization:
Celgene
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes MDS treated with azacitidine have improved survival compared to conventional care treatments The study will also assess the effect of treatments on response duration of response and transformation to acute myeloid leukemia AML The study will continue for 12 months following last patient enrolled
See study AZA PH GL 2003 CL 001 E for information about the extension to this study
See study AZA PH GL 2003 CL 001 E for information about the extension to this study
Detailed Description:
ComparisonControl Interventions offered the physician three options
Best supportive care BSC alone
Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days or
Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline daunorubicin idarubicin or mitoxantrone on Days 1 2 and 3 and for those eligible 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 each cycle between 28 to 70 days from the start of the previous cycle
All three options included best supportive care Neither the experimental group azacitidine nor any of the comparisoncontrol options allowed use of erythropoietin
Duration of Intervention Patients will be treated until death withdrawal unacceptable toxicity or conclusion of the study
Best supportive care BSC alone
Low-dose cytarabine subcutaneously for 14 days every 28 to 42 days or
Standard chemotherapy administered for induction as a continuous intravenous infusion of cytarabine over 7 days plus an anthracycline daunorubicin idarubicin or mitoxantrone on Days 1 2 and 3 and for those eligible 1 or 2 consolidation cycles administered as continuous intravenous infusions of cytarabine for 3 to 7 days with the same anthracycline that was used at induction on Days 1 and 2 each cycle between 28 to 70 days from the start of the previous cycle
All three options included best supportive care Neither the experimental group azacitidine nor any of the comparisoncontrol options allowed use of erythropoietin
Duration of Intervention Patients will be treated until death withdrawal unacceptable toxicity or conclusion of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None