Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-06 @ 2:28 PM
Study NCT ID:
NCT00227695
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2005-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab in Treating Patients With Follicular Non-Hodgkin's Lymphoma
Sponsor:
Swiss Cancer Institute
Organization:
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-Hodgkin's 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-Hodgkin's 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-Hodgkin's 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-Hodgkin's 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-Hodgkin's 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:
False
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?: