Non-Hodgkin's Lymphoma
Conditions
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.
Interventions
DRUGOfatumumab combined with SB-485232
Ofatumumab with escalating doses of SB-485232
Sponsors
Novartis
Michael John Robertson
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed