Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Biological: rituximabOther: No treatment
- 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
- Arm && Interventions
Group Intervention Description Arm C Rituximab 4 and Rixuximab Maintenance rituximab 4 infusions - 375mg/m2 every 2 months. A single dose of rituximab (375mg/m2 will then be given at 12, 20, 28, 36, 44, 52, 60, 68, 76, 84, 92 and 100 weeks Watch and Wait No treatment Watch and Wait - no treatment
- 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 Frequency of clinical spontaneous remission From randomisation until the initiation of chemotherapy in the watch and wait arm Response rate at 25 months Response at 25 months
Trial Locations
- Locations (69)
Mount Vernon Cancer Centre at Mount Vernon Hospital
š¬š§Northwood, England, United Kingdom
West Middlesex University Hospital
š¬š§Isleworth, England, United Kingdom
Royal Alexandra Hospital
š¬š§Paisley, Scotland, United Kingdom
Pembury Hospital
š¬š§Royal Tunbridge Wells, England, United Kingdom
Blackpool Victoria Hospital
š¬š§Blackpool, England, United Kingdom
Kettering General Hosptial
š¬š§Kettering, England, United Kingdom
Kent and Canterbury Hospital
š¬š§Canterbury, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
š¬š§Preston, England, United Kingdom
Leicester Royal Infirmary
š¬š§Leicester, England, United Kingdom
Glan Clwyd Hospital
š¬š§Rhyl, Wales, United Kingdom
Queen Elizabeth Hospital
š¬š§King's Lynn, England, United Kingdom
Royal Devon and Exeter Hospital
š¬š§Exeter, England, United Kingdom
Oldchurch Hospital
š¬š§Romford, England, United Kingdom
Sir James Spence Institute of Child Health at Royal Victoria Infirmary
š¬š§Newcastle-Upon-Tyne, England, United Kingdom
Birmingham Heartlands Hospital
š¬š§Birmingham, England, United Kingdom
St. Helier Hospital
š¬š§Carshalton, England, United Kingdom
Hemel Hempstead General
š¬š§Hemel Hempstead, England, United Kingdom
Maidstone Hospital
š¬š§Maidstone, England, United Kingdom
Hairmyres Hospital
š¬š§East Kilbride, Scotland, United Kingdom
Torbay Hospital
š¬š§Torquay, England, United Kingdom
Royal Marsden - Surrey
š¬š§Sutton, England, United Kingdom
Wishaw General Hospital
š¬š§Wishaw, Scotland, United Kingdom
Velindre Cancer Center at Velindre Hospital
š¬š§Cardiff, Wales, United Kingdom
Royal Adelaide Hospital
š¦šŗAdelaide, Australia
Royal Brisbane and Women's Hospital
š¦šŗBrisbane, Australia
Ashford Cancer Centre
š¦šŗBlack Forest, Australia
Boxhill Hospital
š¦šŗBox Hill, Australia
Canberra Hospital
š¦šŗCanberra, Australia
Fremantle Hospital
š¦šŗFremantle, Australia
Concord Repatriation General Hospital
š¦šŗConcord, Australia
Frankston Hospital
š¦šŗFrankston, Australia
Gosford Hospital
š¦šŗGosford, Australia
Royal Hobart Hospital
š¦šŗHobart, Australia
Nepean Hospital
š¦šŗKingswood, Australia
Lismore Base Hospital
š¦šŗLismore, Australia
Alfred Hospital
š¦šŗMelbourne, Australia
Liverpool Hospital
š¦šŗLiverpool, Australia
Austin Health
š¦šŗMelbourne, Australia
Peter MacCallum Cancer Centre
š¦šŗMelbourne, Australia
St Vincent's Hospital
š¦šŗSydney, Australia
Mater Misericordiae Hospital
š¦šŗNewcastle, Australia
Royal Perth Hospital
š¦šŗPerth, Australia
Royal North Shore Hospital
š¦šŗSt Leonards, Australia
Westmead Hospital
š¦šŗWestmead, Australia
Murray Valley Private Hospital
š¦šŗWodonga, Australia
Wollongong Hospital
š¦šŗWollongong, Australia
Princess Alexandra Hospital
š¦šŗWoolloongabba, Australia
Auckland Hospital
š³šæAuckland, New Zealand
North Shore Hospital
š³šæWestlake, New Zealand
Middlemore Hospital
š³šæAuckland, New Zealand
Christchurch Hospital
š³šæChristchurch, New Zealand
West Suffolk Hospital
š¬š§Bury St. Edmunds, England, United Kingdom
Hull Royal Infirmary
š¬š§Hull, England, United Kingdom
Medway Maritime Hospital
š¬š§Gillingham, England, United Kingdom
St. George's Hospital
š¬š§London, England, United Kingdom
Staffordshire General Hospital
š¬š§Stafford, England, United Kingdom
Aberdeen Royal Infirmary
š¬š§Aberdeen, Scotland, United Kingdom
Weston General Hospital
š¬š§Weston-super-Mare, England, United Kingdom
Monklands General Hospital
š¬š§Airdrie, Scotland, United Kingdom
Worcester Royal Hospital
š¬š§Worcester, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
š¬š§Edinburgh, Scotland, United Kingdom
Southern General Hospital
š¬š§Glasgow, Scotland, United Kingdom
Raigmore Hospital
š¬š§Inverness, Scotland, United Kingdom
Prince Charles Hospital
š¬š§Merthyr Tydfil, Wales, United Kingdom
South West Wales Cancer Institute
š¬š§Swansea, Wales, United Kingdom
Southampton General Hospital
š¬š§Southampton, England, United Kingdom
Royal Cornwall Hospital
š¬š§Truro, England, United Kingdom
Kidderminster Hospital
š¬š§Kidderminster, England, United Kingdom
Alexandra Healthcare NHS
š¬š§Redditch, England, United Kingdom