NCT01768338

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2017

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

3.1 years

First QC Date

January 9, 2013

Last Update Submit

February 8, 2023

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To evaluate the biologic effects of SB-485232 given in combination with ofatumumab

    8 weeks

Study Arms (1)

Ofatumumab combined with SB-485232

EXPERIMENTAL

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

Interventions

Ofatumumab combined with SB-485232DRUG

Ofatumumab with escalating doses of SB-485232

Ofatumumab combined with SB-485232

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Interleukin-18

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Michael Robertson, MD

    Indiana University Melvin and Bren Simon Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 9, 2013

First Posted

January 15, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2016

Study Completion

August 3, 2017

Last Updated

February 10, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)