Phase 2
N=11
Safety and Efficacy Study of Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma
High Risk Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00994643 ↗Enrolled (actual)
11
Serious AEs
45.5%
Results posted
Oct 2017
Primary outcome: Primary: Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma — 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rituximab (Biological); Interleukin-2 (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma |
6 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT00994643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.