Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
Phase 1
Completed
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Registration Number
- NCT01768338
- Lead Sponsor
- Michael John Robertson
- Brief Summary
The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
- Patients who have undergone high-dose therapy and autologous PBSCT for treatment of CD20+ lymphoma.
- Patients must be between 2-6 months post-transplantation at the time of study registration.
- Patients must have at least stable disease (no overt progressive disease) at the time of study registration.
- Laboratory values must be within protocol specified ranges.
- Females of childbearing potential must have a negative pregnancy test.
- Females of childbearing potential and males must use an effective method of contraception from the time of consent until at least 365 days following discontinuation of protocol therapy.
Exclusion Criteria
- Patient must not have obvious clinical progression of lymphoma after PBSCT as determined by the treating physician.
- Cannot be positive for hepatitis B surface antigen, hepatitis B core antibody or HIV antibody.
- No major or uncontrolled comorbid conditions as determined by the treating physician: history of ventricular arrhythmias requiring drug or device therapy; uncontrolled angina or symptomatic congestive heart failure; • severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis C infection; severe or uncontrolled psychiatric illness.
- No known leptomeningeal involvement by lymphoma or current metastatic brain disease.
- No Corrected QTc interval > 480 msec.
- No known or suspected hypersensitivity to ofatumumab or SB-485232 that in the opinion of the investigator is a contraindication to their participation in the study.
- No systemic (oral or parenteral) corticosteroids within 14 days of study entry.
- Not receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other investigational therapy.
- No previous treatment with SB-485232 or ofatumumab.
- No history of other malignancy except for adequately treated non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
- No diabetes mellitus with poor glycemic control (documented hemoglobin A1c >7% within 4 weeks prior to study entry).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ofatumumab combined with SB-485232 Ofatumumab combined with SB-485232 Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.
- Primary Outcome Measures
Name Time Method To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab 8 weeks Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).
- Secondary Outcome Measures
Name Time Method To evaluate the biologic effects of SB-485232 given in combination with ofatumumab 8 weeks Biologic effects will be assessed by flow cytometric analysis of PBMCs and ELISA tests to measure plasma cytokines and chemokines.
Trial Locations
- Locations (1)
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States