Clinical trial NCT00250861 (phase 2, status: terminated)
Conditions: non-hodgkin's lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: rituximab, aldesleukin
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    study terminated due to lack of enrollment.
  
Eligibility 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.