Randomized Phase III Trial Comparing Two Different Rituximab Dosing Regimens For Patients With Low Tumor Burden Indolent Non-Hodgkin's Lymphoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed non-Hodgkin's lymphoma, including 1 of the following:

- Follicular grade 1 or 2

- Small lymphocytic

- Marginal zone (nodal)

- Marginal zone (splenic)

- Mucosa-associated lymphoid tissue (MALT)

- No evidence of transformation to a large cell histology

- Stage III or IV disease

- Must meet the following criteria for low tumor burden:

- No nodal or extranodal mass at least 7 cm

- Less than 3 nodal masses greater than 3 cm in diameter

- No systemic symptoms or B symptoms

- No splenomegaly greater than 16 cm by CT scan

- No evidence of risk of compression of a vital organ (i.e., ureteral or epidural)

- No leukemic phase with greater than 5,000/mm^3 circulating lymphocytes

- No cytopenias, defined as any of the following:

- Platelet count less than 100,000/mm^3

- Hemoglobin less than 10 g/dL

- Absolute neutrophil count less than 1,500/mm^3

- At least 1 objective measurable disease parameter

- Abnormal PET scans will not constitute evaluable disease unless verified by CT
scan or other appropriate imaging

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

- Absolute neutrophil count at least 1,500/mm^3*

- Hemoglobin at least 10 g/dL*

- Platelet count at least 100,000/mm^3* NOTE: *Without growth factor and/or transfusion
support

Hepatic

- Bilirubin no greater than 2 times upper limit of normal (ULN) OR direct bilirubin
normal for patients with Gilbert's Syndrome

- AST/ALT no greater than 5 times ULN

- Hepatitis B surface antigen negative

Renal

- Creatinine no greater than 2 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No uncontrolled active infection

- Afebrile for at least 48 hours off antibiotics

- No other malignancy within the past 2 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Radiotherapy

- No prior immunotherapy for lymphoma

Chemotherapy

- No prior chemotherapy for lymphoma

- No concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for lymphoma

- No concurrent radiotherapy

- No concurrent radioimmunotherapy

Surgery

- Not specified