Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169143
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2005-09-12
Brief Title:
Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Study of R-ACVBP Regimen Supported by Pegfilgrastim in Previously Untreated Patients Aged From 18 to 60 Years With High-Risk Diffuse Large B-Cell Lymphoma Age-adjusted Ipi or 2
Status:
COMPLETED
Status Verified Date:
2018-08
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:
Evaluation of the efficacy of a single injection of Pegfilgrastim 6mg administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20 diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index Aa-IPI
Detailed Description:
This is a phase II multicentric open-label non-randomized study evaluating the efficacy of a single injection of Pegfilgrastim 6mg administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients aged 18 to 60 years with previously untreated CD20 diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index Aa-IPI and eligible for transplant
It is anticipated that 60 subjects will be enrolled over 2 years from 2004 to 2006 in a group sequential manner one planned interim analysis
The duration of the treatment period is approximately 26 weeks and patients are followed until Death
The total Duration of the study is expected to be 25 years
It is anticipated that 60 subjects will be enrolled over 2 years from 2004 to 2006 in a group sequential manner one planned interim analysis
The duration of the treatment period is approximately 26 weeks and patients are followed until Death
The total Duration of the study is expected to be 25 years
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