Long-Term Follow-up Study for Patients Previously Treated With JCAR015

June 2, 2022 updated by: Juno Therapeutics, a Subsidiary of Celgene

Long-Term Follow-up Protocol for Subjects Treated With JCAR015

This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110-1093
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients previously treated with JCAR015 in a prior clinical trial

Description

Inclusion criteria:

  • Patients who have received at least one dose of JCAR015 in a previous treatment protocol.
  • Patients who have provided informed consent for the long-term follow-up study prior to study participation.

Exclusion criteria:

  • None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
JCAR015-treated
Patients who received previous treatment with JCAR015
Genetic: JCAR015
No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with adverse events
Time Frame: Every year for up to 15 years post-treatment
Every year for up to 15 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment
Time Frame: Every 6 months for the first 5 years post-treatment
Every 6 months for the first 5 years post-treatment
Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment
Time Frame: Every year from 5 years post-treatment to up to 15 years post-treatment
Every year from 5 years post-treatment to up to 15 years post-treatment
Survival
Time Frame: Up to 15 years
Up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juno Therapeutics, a Subsidiary of Celgene

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2016

Primary Completion (Actual)

October 22, 2021

Study Completion (Actual)

October 22, 2021

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

June 3, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 015002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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