Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma

This study is currently recruiting participants.
Verified February 2013 by Indiana University
Sponsor:
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
  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 April 15, 2014