Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140582
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2005-08-22
Brief Title:
Primary Rituximab and Maintenance
Sponsor:
Lymphoma Study Association
Organization:
Lymphoma Study Association
Study Overview
Official Title:
Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab MabThera After Induction of Response With Chemotherapy Plus Rituximab in Comparison With no Maintenance Therapy
Status:
COMPLETED
Status Verified Date:
2017-03
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:
Objectives
Primary objective To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy
Secondary objective To evaluate response rates event driven survival endpoints EFS PFS OS and quality of life of four different chemotherapy regimens combined with rituximab with or without maintenance with rituximab for first line treatment of advanced stage follicular lymphoma
Study Design This is an international open-label multicentre randomized study with two treatment phases In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation After the maintenance period patients will be included in the follow up phase for 3 years
Primary objective To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy
Secondary objective To evaluate response rates event driven survival endpoints EFS PFS OS and quality of life of four different chemotherapy regimens combined with rituximab with or without maintenance with rituximab for first line treatment of advanced stage follicular lymphoma
Study Design This is an international open-label multicentre randomized study with two treatment phases In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation After the maintenance period patients will be included in the follow up phase for 3 years
Detailed Description:
Study medication
First period Induction of response with 8 x rituximab combined with 8 cycles of CVP or 6 cycles of CHOP in 21-day cycles or 6 cycles of FCM in 28-day cycles or 6 cycles of MCP in 28-day cycles
Second period rituximab 375 mgm2 every 8 weeks for 24 months 12 injections or control with no treatment
First period Induction of response with 8 x rituximab combined with 8 cycles of CVP or 6 cycles of CHOP in 21-day cycles or 6 cycles of FCM in 28-day cycles or 6 cycles of MCP in 28-day cycles
Second period rituximab 375 mgm2 every 8 weeks for 24 months 12 injections or control with no treatment
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