Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227695
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2005-09-26
Brief Title:
Rituximab in Treating Patients With Follicular Non-Hodgkins Lymphoma
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Comparing Two Schedules of Rituximab Maintenance in Rituximab-Responding Patients With Untreated Chemotherapy Resistant or Relapsed Follicular Lymphoma A Randomized Phase III Trial
Status:
COMPLETED
Status Verified Date:
2019-05
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:
RATIONALE Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them It is not yet known whether giving rituximab over a short period of time is more effective than giving it over a long period of time in treating follicular non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying rituximab to see how well it works when given over a short period of time compared to when given over a long period of time in treating patients with follicular non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy of induction therapy with rituximab followed by short- vs long-term maintenance therapy with rituximab in terms of event-free survival in patients with follicular non-Hodgkins lymphoma
Secondary
Compare the safety of these regimens in these patients
Compare the pharmaeconomical aspects of these regimens in these patients
Compare the evolution of immunologic competence in patients treated with these regimens
OUTLINE This is a randomized multicenter study
Induction therapy Patients receive rituximab IV weekly in weeks 1-4 and undergo restaging between weeks 11-13 Patients with stable disease or progressive disease are taken off study Patients achieving partial or complete response are stratified according to prior treatment status untreated vs treated with or without anti-CD20 therapy presence of bulky disease at study entry yes vs no and participating center Patients are then randomized to 1 of 2 maintenance treatment arms
NOTE Patients treated with radiotherapy only are considered as therapy-naïve
NOTE Defined as a mass or lymph node conglomerate 5 cm diameter
Maintenance therapy Patients start maintenance therapy within 7 days of randomization
Arm I Patients receive rituximab IV every 2 months for 4 treatments
Arm II Patients receive rituximab IV every 2 months for up to 5 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until disease progression or relapse and then annually for up to 10 years after randomization
PROJECTED ACCRUAL A total of 270 patients will be accrued for this study within 3 years
Primary
Compare the efficacy of induction therapy with rituximab followed by short- vs long-term maintenance therapy with rituximab in terms of event-free survival in patients with follicular non-Hodgkins lymphoma
Secondary
Compare the safety of these regimens in these patients
Compare the pharmaeconomical aspects of these regimens in these patients
Compare the evolution of immunologic competence in patients treated with these regimens
OUTLINE This is a randomized multicenter study
Induction therapy Patients receive rituximab IV weekly in weeks 1-4 and undergo restaging between weeks 11-13 Patients with stable disease or progressive disease are taken off study Patients achieving partial or complete response are stratified according to prior treatment status untreated vs treated with or without anti-CD20 therapy presence of bulky disease at study entry yes vs no and participating center Patients are then randomized to 1 of 2 maintenance treatment arms
NOTE Patients treated with radiotherapy only are considered as therapy-naïve
NOTE Defined as a mass or lymph node conglomerate 5 cm diameter
Maintenance therapy Patients start maintenance therapy within 7 days of randomization
Arm I Patients receive rituximab IV every 2 months for 4 treatments
Arm II Patients receive rituximab IV every 2 months for up to 5 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months until disease progression or relapse and then annually for up to 10 years after randomization
PROJECTED ACCRUAL A total of 270 patients will be accrued for this study within 3 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000443594 | None | None | None |
| SWS-SAKK-3503 | None | None | None |
| EU-20520 | None | None | None |