Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed follicular non-Hodgkin's lymphoma Diagnosed within the past 3 months Grade 1, 2, or 3a disease Stage II-IV disease No evidence of histological transformation Bidimensionally measurable disease by clinical examination or radiography Asymptomatic disease without B symptoms or severe pruritus Low tumor burden, defined by all of the following criteria: Lactic dehydrogenase normal Largest nodal or extranodal mass < 7 cm No more than 3 nodal sites with a diameter > 3 cm No clinically detectable significant serous effusion by chest x-ray Clinically non-evident small effusion on CT scan is not considered significant Spleen enlargement ≤ 16 cm by CT scan Circulating tumor cells < 5,000/mm^3 No organ compression (i.e., ureteric obstruction) PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Absolute neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 10 g/dL Hepatic AST and ALT normal Alkaline phosphatase normal Bilirubin normal Renal Creatinine < 2 times upper limit of normal (unless due to lymphoma) Other Not pregnant or nursing Fertile patients must use effective contraception during and for 12 months after completion of rituximab No known HIV positivity No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No critical organ failure No other immediate life-threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No prior therapy for lymphoma
Sites / Locations
- Queen Elizabeth Hospital
- Royal Adelaide Hospital
- Ashford Cancer Centre
- Boxhill Hospital
- Royal Brisbane and Women's Hospital
- Canberra Hospital
- Concord Repatriation General Hospital
- Frankston Hospital
- Fremantle Hospital
- Gosford Hospital
- Royal Hobart Hospital
- Nepean Hospital
- Lismore Base Hospital
- Liverpool Hospital
- Alfred Hospital
- Austin Health
- Peter MacCallum Cancer Centre
- St Vincent's Hospital
- Mater Misericordiae Hospital
- Royal Perth Hospital
- Royal North Shore Hospital
- St Vincent's Hospital
- Westmead Hospital
- Murray Valley Private Hospital
- Wollongong Hospital
- Princess Alexandra Hospital
- Auckland Hospital
- Middlemore Hospital
- Christchurch Hospital
- North Shore Hospital
- Birmingham Heartlands Hospital
- Blackpool Victoria Hospital
- West Suffolk Hospital
- Kent and Canterbury Hospital
- St. Helier Hospital
- Royal Devon and Exeter Hospital
- Queen Elizabeth Hospital
- Medway Maritime Hospital
- Hemel Hempstead General
- Hull Royal Infirmary
- West Middlesex University Hospital
- Kettering General Hosptial
- Kidderminster Hospital
- Queen Elizabeth Hospital
- Leicester Royal Infirmary
- St. George's Hospital
- Maidstone Hospital
- Sir James Spence Institute of Child Health at Royal Victoria Infirmary
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Rosemere Cancer Centre at Royal Preston Hospital
- Alexandra Healthcare NHS
- Oldchurch Hospital
- Pembury Hospital
- Southampton General Hospital
- Staffordshire General Hospital
- Royal Marsden - Surrey
- Torbay Hospital
- Royal Cornwall Hospital
- Weston General Hospital
- Worcester Royal Hospital
- Aberdeen Royal Infirmary
- Monklands General Hospital
- Hairmyres Hospital
- Edinburgh Cancer Centre at Western General Hospital
- Southern General Hospital
- Raigmore Hospital
- Royal Alexandra Hospital
- Wishaw General Hospital
- Velindre Cancer Center at Velindre Hospital
- Prince Charles Hospital
- Glan Clwyd Hospital
- South West Wales Cancer Institute
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Watch and Wait
Arm C Rituximab 4 and Rixuximab Maintenance
Watch and Wait - no treatment
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