Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Registration Number
- NCT00112931
- Lead Sponsor
- University College, London
- 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-Hodgkin's 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-Hodgkin's 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-Hodgkin's 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 462
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time until initiation of therapy (chemotherapy or radiotherapy) Time from randomisation until the first day systemic chemotherapy or radiotherapy is given. If rituximab is given to patients in the watch and wait arm this will be considered as initiation of chemotherapy.
- Secondary Outcome Measures
Name Time Method Overall survival Time from randomisation to death from any cause. Cause specific survival Time from randomisation to death from lymphoma or immediate therapy related toxicity Response rate at 25 months Response at 25 months Frequency of clinical spontaneous remission From randomisation until the initiation of chemotherapy in the watch and wait arm
Trial Locations
- Locations (69)
Queen Elizabeth Hospital
🇬🇧King's Lynn, England, United Kingdom
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Ashford Cancer Centre
🇦🇺Black Forest, Australia
Boxhill Hospital
🇦🇺Box Hill, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Australia
Canberra Hospital
🇦🇺Canberra, Australia
Concord Repatriation General Hospital
🇦🇺Concord, Australia
Frankston Hospital
🇦🇺Frankston, Australia
Fremantle Hospital
🇦🇺Fremantle, Australia
Gosford Hospital
🇦🇺Gosford, Australia
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