NCT03165188

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
terminated

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

May 22, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

3.3 years

First QC Date

May 22, 2017

Last Update Submit

April 4, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects with adverse events.

    Up to 15 years

  • Survival

    Up to 15 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Research subjects who have received at least one dose of algenpantucel-L immunotherapy in clinical trials.

You may qualify if:

  • Receipt of at least one dose of algenpantucel-L within the past 15 years
  • Signed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University Cancer Center

Palo Alto, California, 94305, United States

Location

UF Health Cancer Center

Gainesville, Florida, 32610, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Indiana University Health Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

UT Health Cancer Center

San Antonio, Texas, 78229, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 24, 2017

Study Start

September 1, 2017

Primary Completion

December 8, 2020

Study Completion

December 8, 2020

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations