Long-term Follow-up Study for Patients Previously Treated With a Juno CAR T-Cell Product

April 30, 2020 updated by: Juno Therapeutics, a Subsidiary of Celgene

Long-Term Follow-up Protocol for Subjects Treated With a CAR T-Cell Product on a Juno-Sponsored Clinical Trial

This study will provide long-term follow-up for patients who have received treatment with a Juno CAR T-cell product in a Juno-sponsored clinical trial. In this study, patients will be followed for up to 15 years after their last dose of Juno CAR T cells for evaluation of delayed adverse events, presence of persisting CAR T-cell vector sequences, presence of replication-competent retrovirus (RCR) or lentivirus (RCL), and survival.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4

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
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients previously treated with a Juno CAR T-cell product on a Juno-sponsored clinical trial

Description

Inclusion Criteria:

  • Patients who have received at least one dose of a Juno CAR T-cell product (listed above) in a Juno-sponsored clinical trial
  • Patients who have provided informed consent for the long-term follow-up study

Exclusion Criteria:

  • None. All patients who have previously received treatment with a Juno CAR T-cell product 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
JCAR017-treated
Patients who received previous treatment with JCAR017
Genetic: JCAR017
No drug is administered in this study. Patients who received JCAR017 in a previous trial will be evaluated in this trial for long-term safety and survival.
JCARH125-treated
Patients who received previous treatment with JCARH125
Genetic: JCARH125
No drug is administered in this study. Patients who received JCARH125 in a previous trial will be evaluated in this trial for long-term safety and survival.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with adverse events
Time Frame: 15 years from last treatment
15 years from last treatment
Proportion of patients with detectable viral vector sequences
Time Frame: 15 years from last treatment
15 years from last treatment
Proportion of patients with detectable RCR or RCL
Time Frame: 15 years from last treatment
15 years from last treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 15 years from last treatment
15 years from last treatment
Progression-free survival
Time Frame: 15 years from last treatment
15 years from last treatment

Collaborators and Investigators

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

Sponsor

Juno Therapeutics, a Subsidiary of Celgene

Investigators

  • Study Director: Jacob Garcia, MD, Sponsor GmbH

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)

February 19, 2018

Primary Completion (Actual)

July 20, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

February 12, 2018

First Posted (Actual)

February 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2020

Last Update Submitted That Met QC Criteria

April 30, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LTFU001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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