Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Plain-language summary

This is a long-term follow-up protocol designed to monitor participants who have previously received gene-modified T-cell therapy. People who received at least one gene-modified T-cell infusion in a prior Celgene, Juno Therapeutics or affiliated trial and have completed that study's follow-up period may take part. The study is being conducted in Phase 2/Phase 3 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

PHASE2/PHASE3

Status

Recruiting

Sponsor

Celgene

Intervention

Gene-modified (GM) T cell therapy

Start date

7/19/2018

Estimated completion

11/30/2036

Countries

United States, Australia, Austria, Belgium, Canada, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Poland, Romania, South Korea, Spain, Sweden, Switzerland, United Kingdom

Related genes

Locations

• Birmingham, United States
• Gilbert, United States
• Phoenix, United States
• Scottsdale, United States
• Tucson, United States
• Duarte, United States
• La Jolla, United States
• Los Angeles, United States
• Sacramento, United States
• San Francisco, United States
• Santa Monica, United States
• Stanford, United States
• Aurora, United States
• Denver, United States
• New Haven, United States
• Washington D.C., United States
• Jacksonville, United States
• Miami, United States
• Orlando, United States
• Tampa, United States
• Atlanta, United States
• Atlanta, United States
• Chicago, United States
• Chicago, United States
• Maywood, United States
• Niles, United States
• Indianapolis, United States
• Indianapolis, United States
• Indianapolis, United States
• Westwood, United States
• Wichita, United States
• Lexington, United States
• Louisville, United States
• New Orleans, United States
• Baltimore, United States
• Baltimore, United States
• Bethesda, United States
• Boston, United States
• Boston, United States
• Boston, United States

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Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.
* Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.

Exclusion Criteria:

Not Applicable

Other protocol-defined inclusion/exclusion criteria apply