Clinical trial · Interventional
Safety and Efficacy Study of Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma
Phase II Study of IL-2 and Rituximab Maintenance in High Risk B Cell Non-Hodgkin's Lymphoma
NCT00994643CI-TRIAL-00089077completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High Risk Non-Hodgkin's Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interleukin-2 | Biological | Aldesleukin | ALIAS |
| Rituximab | Biological | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (Interleukin Therapy, Monoclonal Antibody)
- description
- Patients receive interleukin-2 SC twice weekly and rituximab IV once weekly in weeks 5-8 and 25-28. Courses repeat every 4 weeks for up to 7 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: Rituximab
- Biological: Interleukin-2
Primary outcomes (1)
- measure
- Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma
- timeFrame
- 1 year
- description
- Patients were enrolled based on having obtained complete remission or at least a partial remission. Efficacy was therefore determined by the number of patients that remained in remission following treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.