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NCT03165188 Clinical Trial

Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

Pancreatic Cancer Clinical Trial

Official title:
Long Term Follow-Up Study for Subjects Previously Treated With Algenpantucel-L (HyperAcute-Pancreas) Immunotherapy

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03165188
Other study ID # NLG0705
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date December 8, 2020

Study information
Verified date April 2022
Source Lumos Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This protocol (NLG0705) provides a mechanism for the 15-year follow-up period that the FDA requires for all participants in gene transfer protocols and assures that adequate follow-up can be maintained for subjects who have received at least one dose of algenpantucel-L.

Recruitment information / eligibility
Status Terminated
Enrollment 29
Est. completion date December 8, 2020
Est. primary completion date December 8, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Receipt of at least one dose of algenpantucel-L within the past 15 years - Signed consent

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Northwestern University Chicago Illinois
United States UT Southwestern Medical Center Dallas Texas
United States NorthShore University HealthSystem Evanston Illinois
United States UF Health Cancer Center Gainesville Florida
United States Indiana University Health Goshen Center for Cancer Care Goshen Indiana
United States Baylor College of Medicine Houston Texas
United States Cedars-Sinai Medical Center Los Angeles California
United States University of Louisville Louisville Kentucky
United States University of Wisconsin Madison Wisconsin
United States Stanford University Cancer Center Palo Alto California
United States UPMC Hillman Cancer Center Pittsburgh Pennsylvania
United States Oregon Health and Science University Portland Oregon
United States Washington University Saint Louis Missouri
United States UT Health Cancer Center San Antonio Texas
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
NewLink Genetics Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of subjects with adverse events. Up to 15 years
Primary Survival Up to 15 years
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