Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

OBJECTIVES:

Primary

- To determine the response rate (overall and complete) after extended induction therapy
comprising epratuzumab and rituximab in patients with previously untreated CD20+
follicular non-Hodgkin lymphoma (NHL).

- To determine the time to progression after extended induction therapy comprising
epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.

Secondary

- To determine the toxicity profile of epratuzumab and rituximab in patients with
previously untreated CD20+ follicular NHL.

- To establish whether the therapeutic effects of the combination of epratuzumab and
rituximab are sufficiently promising to warrant evaluation in a subsequent randomized
trial (in comparison to rituximab alone).

- To determine the relationship between the change in fludeoxyglucose F 18 uptake early
after epratuzumab and rituximab treatment with response rate and time to progression.

OUTLINE:

- Induction therapy (month 1): Patients receive epratuzumab IV over 5-30 minutes on days
1, 8, 15, and 22 and rituximab IV on days 3, 8, 15, and 22 in the absence of disease
progression or unacceptable toxicity.

- Extended induction therapy (months 3, 5, 7, and 9): Patients receive epratuzumab IV
over 5-30 minutes followed by rituximab IV in weeks 12, 20, 28, and 36 in the absence
of disease progression or unacceptable toxicity.

Patients receive fludeoxyglucose F 18 (FDG) subcutaneously and undergo positron emission
tomography at baseline and after induction therapy to assess the degree of FDG uptake.

After completion of study treatment, patients are followed every 4 months for 2 years then
every 6 months for up to 10 years.

DISEASE CHARACTERISTICS:

- Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)

- Previously untreated disease

- WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field
with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7
cm in any unidimensional measurement) stage II disease NOTE: *Bone marrow
biopsies as the sole means of diagnosis are not acceptable, but they may be
submitted in conjunction with nodal biopsies; fine-needle aspirates are not
acceptable for diagnosis

- Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry

- Measurable disease by physical examination or imaging studies

- Any tumor mass > 1 cm is acceptable

- No nonmeasurable disease only, including any of the following:

- Bone lesions

- Ascites

- Pleural/pericardial effusion

- Lymphangitis cutis/pulmonis

- Bone marrow (involvement by NHL should be noted)

- No known CNS involvement by lymphoma

- Required to participate in companion FDG-PET imaging study CALGB 580701

PATIENT CHARACTERISTICS:

- ECOG performance status ≤ 2

- Absolute neutrophil count ≥ 1,000/μL

- Platelet count ≥ 50,000/μL

- Patients with HIV infection are eligible provided they meet the following criteria:

- No evidence of coinfection with hepatitis B or C

- CD4+ cell count ≥ 400/mm^3

- No evidence of resistant strains of HIV

- If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL

- If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL

- No history of AIDS-defining conditions

- Not pregnant or nursing

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

- No known Human Anti-Chimeric Antibody (HACA)-positivity

PRIOR CONCURRENT THERAPY:

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

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

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

- Treatment of acute infusion reactions according to institutional procedures

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

- No other concurrent chemotherapeutic agents