A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed* previously untreated follicular non-Hodgkin's lymphoma
(NHL), meeting 1 of the following stage criteria:

- Bulky stage II disease (i.e., at least 1 unidimensionally measurable mass ≥ 7
cm)

- Stage III or IV disease NOTE: *Bone marrow biopsy as the sole means of diagnosis
is not acceptable; fine needle aspiration is not acceptable

- WHO grade 1, 2, or 3a disease (i.e., > 15 centroblasts per high power field with
centrocytes present)

- CD20-positive disease by flow cytometry or immunohistochemistry

- Measurable disease by physical examination or imaging studies

- Tumor mass > 1 cm

- Patients with only nonmeasurable disease are not eligible

- The following are considered nonmeasurable disease:

- Bone lesions

- Ascites

- Pleural or pericardial effusion

- Lymphangitis cutis or pulmonis

- Bone marrow lesions

- No known CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 50,000/mm^3

Hepatic

- Bilirubin ≤ 2 times upper limit of normal (ULN)* NOTE: *Unless due to lymphoma or
Gilbert's disease

Renal

- Creatinine ≤ 2 times ULN* NOTE: *Unless due to lymphoma

Immunologic

- No known HIV positivity

- HIV negative (for patients with a history of IV drug abuse or any behavior
associated with an increased risk for HIV infection)

- No known human anti-chimeric antibody positivity

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after
completion of study treatment

- No other currently active* malignancy (including Waldenstrom's macroglobulinemia)
except nonmelanoma skin cancer NOTE: *Patients who have completed prior anticancer
therapy AND have < 30% risk for relapse are not considered to have a currently active
malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy (e.g., monoclonal antibody-based therapy) for NHL

Chemotherapy

- No prior chemotherapy for NHL

- No concurrent chemotherapy

Endocrine therapy

- More than 2 weeks since prior corticosteroids except as maintenance therapy for a
non-malignant disease

- No concurrent hormonal therapy except steroids for adrenal failure OR hormones for
non-disease-related conditions (e.g., insulin for diabetes)

- No concurrent dexamethasone or other steroidal antiemetics except for the following
circumstances:

- Acute grade 3 or 4 monoclonal antibody-associated infusion reaction not
responsive to transient discontinuation of antibody infusion or acetaminophen
and diphenhydramine

- Retreatment after an infusion reaction

Radiotherapy

- No prior radiotherapy for NHL

Surgery

- Not specified