Safety and Efficacy Study of Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma
Condition: High Risk Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Rituximab; Interleukin-2
Intervention description: Given IV; Given SC
Intervention MeSH terms: Aldesleukin; Rituximab; Antineoplastic Agents, Immunological; Interleukin-2; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NHL; Non Hodgkin's Lymphoma; Lymphoma

Summary:

      This is a study to see if maintenance therapy with low dose interleukin-2 (IL-2) and
      rituximab can delay or prevent recurrences in patients with high risk Non-Hodgkin's Lymphoma
      (NHL). IL-2 is a naturally occurring cytokine in our immune system which may enhance the
      activity of a known therapeutic agent rituximab, a monoclonal antibody against CD-20, in the
      setting of NHL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed CD20 B cell non-Hodgkin's lymphoma

          -  Karnofsky performance status scores of 70 or greater (ECOG performance status 0 to 2).

          -  Age greater than 18.

          -  Eligible patients will start treatment between D+30 and D+100 from end of prior
             therapy

          -  Patients have obtained a complete remission after induction chemotherapy or salvage
             chemotherapy who are not candidates for autologous stem cell transplantation or at
             least a partial remission after autologous transplantation (Stem cell collection, if
             indicated, should be collected prior to starting therapy)

          -  International Prognostic Index (IPI)* or Follicular Lymphoma IPI (FLIPI)of 3 or more

          -  Adequate organ function that has been determined within 2 weeks prior to the study
             entry, defined as:

          -  Absolute neutrophil count (ANC) >/=1000/mm3, platelets >/=100,000/mm3, and hemoglobin
             >/=8 g/dl.

          -  Serum bilirubin < 1.5 times ULN and serum albumin > 2.0 g/dl.

          -  If female, neither pregnant (negative pregnancy test) nor breast-feeding.

          -  If of child bearing potential (< one year post-menopausal), must agree to practice an
             effective method of avoiding pregnancy (including oral or implanted contraceptives,
             intrauterine device, condom, diaphragm with spermicidal, cervical cap, abstinence or
             sterile sex partner) from the time informed consent is signed.

          -  No other concurrent active malignancy requiring treatment.

          -  Able to render informed consent and to follow protocol requirements.

        Exclusion Criteria:

          -  CNS lymphoma

          -  Presence of any other medical complications which imply a survival of less than three
             months.

          -  Prior IL-2 therapy

          -  HIV or Viral Hepatitis

          -  Karnofsky performance score less than 70.

          -  Pregnancy or breast-feeding.

          -  Unable or unwilling to utilize contraception if of childbearing potential.

          -  Severe cardiovascular disease within 12 months including myocardial infarction,
             severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
             congestive heart failure, cerebrovascular accident or transient ischemic attach,
             pulmonary embolism, life threatening arrhythmias, or uncontrollable hypertension.

          -  Autoimmune disorders

          -  Concurrent immunosuppressive medications

          -  Concurrent systemic corticosteroids at doses greater than replacement levels

          -  Prior history of intolerance to rituximab