Ignite Creation Date:
2024-05-05 @ 9:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00801281
Status:
COMPLETED
Last Update Posted:
2017-07-17
First Post:
2008-12-02
Brief Title:
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R Maintenance
Sponsor:
Polish Lymphoma Research Group
Organization:
Polish Lymphoma Research Group
Study Overview
Official Title:
First-line R-CVP vs R-CHOP Induction Immunochemotherapy for Indolent Lymphoma and R MaintenanceA Multicentre Phase III Randomized Study by the PLRG
Status:
COMPLETED
Status Verified Date:
2017-07
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:
PLRG4
Brief Summary:
Evaluation of event free survival EFS of patients treated with the study chemotherapy induction program R-CHOP compared to the standard R-CVP regimen and response rates time to best response PFS OS neutropenic fever rate infection rate change in Ig levels change in lymphocyte subpopulations counts in previously untreated indolent lymphoma patients in need of systemic treatment
Detailed Description:
Min 3 max 8 induction cycles Maintenance with rituximab q 2 months x 1224 months started 2 months after last chemotherapy
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