Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
This study is currently recruiting participants.
Verified February 2013 by Indiana University
Sponsor:
Indiana University
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01768338
First received: January 9, 2013
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: Ofatumumab combined with SB-485232 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Indiana University:
Primary Outcome Measures:
- To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Biologic effects will be assessed by flow cytometric analysis of PBMCs and ELISA tests to measure plasma cytokines and chemokines.
| Estimated Enrollment: | 18 |
| Study Start Date: | February 2013 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ofatumumab combined with SB-485232
Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 100 ug/kg) for 8 weeks.
|
Drug: Ofatumumab combined with SB-485232
Ofatumumab with escalating doses of SB-485232
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768338
Contacts
| Contact: Jill Weisenbach, RN | 317-278-0597 | jweisenb@iupui.edu |
| Contact: Michael Robertson, MD | 317-948-6942 | mjrobert@iupui.edu |
Locations
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Jill Weisenbach, RN 317-278-0597 jweisenb@iupui.edu | |
| Contact: Michael Robertson, MD 317-948-6942 mjrobert@iupui.edu | |
| Principal Investigator: Michael Robertson, MD | |
Sponsors and Collaborators
Indiana University
GlaxoSmithKline
Investigators
| Principal Investigator: | Michael Robertson, MD | Indiana University Melvin and Bren Simon Cancer Center |
More Information
No publications provided
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT01768338 History of Changes |
| Other Study ID Numbers: | IUCRO-0397, 1210009882 |
| Study First Received: | January 9, 2013 |
| Last Updated: | February 27, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013