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Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

CompletedPhase 3

Sponsor: University College, London

Conditions: Lymphoma

Interventions: rituximab, No treatment

Countries: Australia, New Zealand, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (72)

Adelaide, Australia
Adelaide, Australia
Black Forest, Australia
Box Hill, Australia
Brisbane, Australia
Canberra, Australia
Concord, Australia
Frankston, Australia
Fremantle, Australia
Gosford, Australia
Hobart, Australia
Kingswood, Australia
Lismore, Australia
Liverpool, Australia
Melbourne, Australia
Melbourne, Australia
Melbourne, Australia
Melbourne, Australia
Newcastle, Australia
Perth, Australia
St Leonards, Australia
Sydney, Australia
Westmead, Australia
Wodonga, Australia
Wollongong, Australia
Woolloongabba, Australia
Auckland, New Zealand
Auckland, New Zealand
Christchurch, New Zealand
Westlake, New Zealand
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