Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Michael John Robertson
With
Novartis
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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).
