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
3 other identifiers
interventional
11
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2009
CompletedFirst Submitted
Initial submission to the registry
October 12, 2009
CompletedFirst Posted
Study publicly available on registry
October 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2015
CompletedResults Posted
Study results publicly available
October 6, 2017
CompletedApril 30, 2025
April 1, 2025
5.4 years
October 12, 2009
May 10, 2017
April 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess the Efficacy of Combination Immunotherapy With Rituximab and Interleukin-2 in Patients With Non-Hodgkin's Lymphoma
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.
1 year
Study Arms (1)
Treatment (Interleukin Therapy, Monoclonal Antibody)
EXPERIMENTALPatients 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.
Interventions
Given IV
Given SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Matthew Carabasi
- Organization
- Thomas Jefferson University
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Carabasi, MD
Thomas Jefferson University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2009
First Posted
October 14, 2009
Study Start
February 5, 2009
Primary Completion
June 25, 2014
Study Completion
June 25, 2015
Last Updated
April 30, 2025
Results First Posted
October 6, 2017
Record last verified: 2025-04