Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768338
• Other study ID #: IUCRO-0397
• Secondary ID: 1210009882
• Status: Completed
• Phase: Phase 1
• Start date: February 2013
• Est. completion date: August 3, 2017

Study information

• Verified date: February 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 3, 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lymphoma
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Ofatumumab combined with SB-485232
Ofatumumab with escalating doses of SB-485232

Locations

Country	Name	City	State
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Michael John Robertson	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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