Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Indiana University
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01768338
First received: January 9, 2013
Last updated: May 30, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 30, 2014
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 July 20, 2014