Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
Conditions
Non-Hodgkin's Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Study Type
Interventional
Study Phase
Phase 1
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Ofatumumab combined with SB-485232
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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).
Location
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Jill Weisenbach, RN - 317-278-0597 - jweisenb@iupui.edu
Start Date
February 2013
Sponsors
Michael John Robertson
Source
Indiana University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page