Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/18/2018 |
Start Date: | February 2013 |
End Date: | August 3, 2017 |
A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma
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.
what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.
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).
We found this trial at
1
site
535 Barnhill Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(888) 600-4822
Principal Investigator: Michael Robertson, MD
Phone: 317-278-0597
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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