A Randomized Phase II Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for CD20 Positive Aggressive Non-Hodgkin's Lymphoma Following High Dose Therapy With Autologous PBSC Rescue

Inclusion Criteria

INCLUSION CRITERIA:

A patient will be eligible for inclusion in this study if s/he meets all of the following
criteria:

- Has previously undergone BEAC or BEAM autologus SCT with PBSC rescue for any stage
aggressive B-cell NHL, including transformed indolent NHL or mantle cell lymphoma
according to REAL classification - only B-cell lymphomas are permitted.

- ECOG performance status 0-1.

- Previously histological documented CD20 +NHL.

- Is greater than 18 years of age.

- Is 30-100 days from autologous peripheral blood stem cell transplant.

- Must meet laboratory values (see protocol for values): Absolute neutrophils,
hemoglobin and platelets.

- Has a negative serum pregnancy test within 7 days prior to trial registration (only
for female patients of childbearing potential).

- If fertile, patient (male or female) has agreed to use physician-approved method of
birth control to avoid pregnancy for the duration of the study and for a period of 3
months thereafter.

- Has signed a Patient Informed Consent Form.

- Has signed a Patient Authorization Form (HIPAA).

EXCLUSION CRITERIA:

Patients will be taken off treatment if any of the following occur:

- ECOG PS >2.

- A history of hypersensitivity to study drugs, or any component thereof, or
anaphylactic history to murine protein.

- Manifested cardiac complications during transplant, including arrthymias, congestive
heart failure, angina, or myocardial infarct, or had a decreased LVEF to <45% prior
to transplant

- On systemic corticosteroids.

- Diffusion capacity <60% (corrected) and has decreased 30% or more following
transplant

- Documented disease progression (See Section 10.1.6 for definition).

- Active infection, and/or is known to be seropositive for hepatitis B, hepatitis C, or
HIV

- Pericardial effusion, pleural effusions, or ascites.

- A history of very aggressive NHL, such as Burkitt's or atypical Burkitt's lymphoma

- Receiving concurrent immunotherapy or rituximab therapy.

- Previously received a solid organ transplant.

- History of CNS involvement.

- A serious uncontrolled intercurrent medical or psychiatric illness, including serious
infection

- A history of other malignancy within the last 5 years (except cured basal cell
carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the
diagnosis or assessment of any of the study drugs.

- A pregnant or nursing woman.

- Unable to comply with requirements of study.