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Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01768338
First Posted: January 15, 2013
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by (Responsible Party):
Michael John Robertson, Indiana University
  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: None (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 Michael John Robertson, 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 ]
    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 ]
    Biologic effects will be assessed by flow cytometric analysis of PBMCs and ELISA tests to measure plasma cytokines and chemokines.


Enrollment: 9
Study Start Date: February 2013
Estimated Study Completion Date: June 2018
Primary Completion Date: March 2016 (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 30 ug/kg) for 8 weeks.
Drug: Ofatumumab combined with SB-485232
Ofatumumab with escalating doses of SB-485232

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768338


Locations
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Michael John Robertson
Novartis
Investigators
Principal Investigator: Michael Robertson, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Responsible Party: Michael John Robertson, Professor of Medicine, Indiana University
ClinicalTrials.gov Identifier: NCT01768338     History of Changes
Other Study ID Numbers: IUCRO-0397
1210009882 ( Other Identifier: Indiana University Institutional Review Board )
First Submitted: January 9, 2013
First Posted: January 15, 2013
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ofatumumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs