A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma
- Patients who have undergone high-dose therapy and autologous PBSCT for treatment of
- Patients must be between 2-6 months post-transplantation at the time of study
- 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.
- 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
- 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
- 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).