Clinical trial NCT01768338: Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
Official title: A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2013-01-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
timeFrame: 8 weeks
Secondary outcomes:
measure: To evaluate the biologic effects of SB-485232 given in combination with ofatumumab
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University Melvin and Bren Simon Cancer Center
name: Michael Robertson, MD
role: PRINCIPAL_INVESTIGATOR
References: