Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
Primary Purpose
Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ofatumumab combined with SB-485232
Sponsored by
About this trial
This is an interventional treatment trial for 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).
Sites / Locations
- Indiana University Melvin and Bren Simon Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ofatumumab combined with SB-485232
Arm Description
Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.
Outcomes
Primary Outcome Measures
To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
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 Outcome Measures
To evaluate the biologic effects of SB-485232 given in combination with ofatumumab
Biologic effects will be assessed by flow cytometric analysis of PBMCs and ELISA tests to measure plasma cytokines and chemokines.
Full Information
NCT ID
NCT01768338
First Posted
January 9, 2013
Last Updated
February 8, 2023
Sponsor
Michael John Robertson
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT01768338
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
August 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael John Robertson
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ofatumumab combined with SB-485232
Arm Type
Experimental
Arm Description
Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Ofatumumab combined with SB-485232
Intervention Description
Ofatumumab with escalating doses of SB-485232
Primary Outcome Measure Information:
Title
To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To evaluate the biologic effects of SB-485232 given in combination with ofatumumab
Description
Biologic effects will be assessed by flow cytometric analysis of PBMCs and ELISA tests to measure plasma cytokines and chemokines.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Robertson, MD
Organizational Affiliation
Indiana University Melvin and Bren Simon Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
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