Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma

A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma

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.

Study Overview

• Status: Completed
• Conditions: Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: Ofatumumab combined with SB-485232

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Melvin and Bren Simon Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Michael John Robertson
• Collaborators: Novartis
• Investigators: Principal Investigator: Michael Robertson, MD, Indiana University Melvin and Bren Simon Cancer Center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): August 3, 2017

Study Registration Dates

• First Submitted: January 9, 2013
• First Submitted That Met QC Criteria: January 11, 2013
• First Posted (ESTIMATE): January 15, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Antineoplastic Agents; Ofatumumab
• Other Study ID Numbers: IUCRO-0397; 1210009882 (OTHER: Indiana University Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO