Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112931
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2005-06-02
Brief Title:
Rituximab in Treating Patients With Newly Diagnosed Stage II Stage III or Stage IV Follicular Non-Hodgkins Lymphoma
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
An Intergroup Randomised Trial of Rituximab Versus a Watch and Wait Strategy in Patients With Advanced Stage Asymptomatic Non-Bulky Follicular Lymphoma
Status:
COMPLETED
Status Verified Date:
2024-05
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 rituximab is more effective than observation in treating non-Hodgkins lymphoma
PURPOSE This randomized phase III trial is studying rituximab to see how well it works compared to observation in treating patients with newly diagnosed stage II stage III or stage IV follicular non-Hodgkins lymphoma with no symptoms
PURPOSE This randomized phase III trial is studying rituximab to see how well it works compared to observation in treating patients with newly diagnosed stage II stage III or stage IV follicular non-Hodgkins lymphoma with no symptoms
Detailed Description:
OBJECTIVES
Primary
Compare time to initiation of systemic chemotherapy or radiotherapy in patients with newly diagnosed previously untreated asymptomatic stage II-IV non-bulky follicular non-Hodgkins lymphoma treated with rituximab vs observation only
Secondary
Compare the frequency of clinical spontaneous remission in patients treated with these regimens
Compare overall and cause-specific survival of patients treated with these regimens
Determine the effect of rituximab on complete and partial response in patients treated with subsequent systemic chemotherapy
Compare quality of life in terms of functional well-being and anxiety and depression of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center disease grade 1 vs 2 vs 3a disease stage II vs III vs IV and age Patients are randomized to 1 of 3 treatment arms
Arm I Patients undergo observation only until disease progression
Arm II Patients receive induction rituximab IV on day 1 Treatment repeats weekly for up to 4 weeks
Arm III Patients receive induction rituximab as in arm II Patients then receive maintenance rituximab IV once on day 1 of weeks 12 20 28 36 44 52 60 68 76 84 92 and 100
In all arms treatment continues in the absence of unacceptable toxicity or disease progression requiring systemic chemotherapy or radiotherapy
NOTE Rituximab administration in arm I is considered initiation of systemic chemotherapy
Quality of life is assessed at baseline before and after randomization every 2 months for 2 years and then every 6 months for 2 years
Patients are followed every 2 months for 2 years and then every 3 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 600 patients 200 per treatment arm will be accrued for this study within 3 years
Primary
Compare time to initiation of systemic chemotherapy or radiotherapy in patients with newly diagnosed previously untreated asymptomatic stage II-IV non-bulky follicular non-Hodgkins lymphoma treated with rituximab vs observation only
Secondary
Compare the frequency of clinical spontaneous remission in patients treated with these regimens
Compare overall and cause-specific survival of patients treated with these regimens
Determine the effect of rituximab on complete and partial response in patients treated with subsequent systemic chemotherapy
Compare quality of life in terms of functional well-being and anxiety and depression of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center disease grade 1 vs 2 vs 3a disease stage II vs III vs IV and age Patients are randomized to 1 of 3 treatment arms
Arm I Patients undergo observation only until disease progression
Arm II Patients receive induction rituximab IV on day 1 Treatment repeats weekly for up to 4 weeks
Arm III Patients receive induction rituximab as in arm II Patients then receive maintenance rituximab IV once on day 1 of weeks 12 20 28 36 44 52 60 68 76 84 92 and 100
In all arms treatment continues in the absence of unacceptable toxicity or disease progression requiring systemic chemotherapy or radiotherapy
NOTE Rituximab administration in arm I is considered initiation of systemic chemotherapy
Quality of life is assessed at baseline before and after randomization every 2 months for 2 years and then every 6 months for 2 years
Patients are followed every 2 months for 2 years and then every 3 months thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 600 patients 200 per treatment arm 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 |
|---|---|---|---|
| ROCHE-CRUK-001621-16 | None | None | None |
| CRUK-2004-001621-16 | None | None | None |
| EU-20509 | None | None | None |