Status:
COMPLETED
Safety and Efficacy Study of Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
High Risk Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 natur...
Detailed Description
Interleukin 2 (IL-2) is a naturally circulating cytokine produced by immune cells including T cells, dendritic cells and thymic cells. IL-2 is an integral part of T cell proliferation, autoimmunity an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 5 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2015
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00994643
Start Date
February 5 2009
End Date
June 25 2015
Last Update
April 30 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107