Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
This trial is active, not recruiting.
|Treatment||ofatumumab combined with sb-485232|
|Sponsor||Michael John Robertson|
|Start date||February 2013|
|End date||March 2016|
|Trial size||9 participants|
|Trial identifier||NCT01768338, 1210009882, IUCRO-0397|
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.
|Intervention model||single group assignment|
Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.
To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
time frame: 8 weeks
To evaluate the biologic effects of SB-485232 given in combination with ofatumumab
time frame: 8 weeks
Male or female participants at least 18 years old.
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).
|Official title||A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma|
|Principal investigator||Michael Robertson, MD|
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