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

Phase 2

Recruiting

• Conditions: Neoplasms

• Registration Number: NCT03435796
• Lead Sponsor: Celgene

Brief Summary

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Study Start: 2018-07-19
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-25
• Primary Completion: 2036-11-30
• Study Completion: 2036-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1541

Inclusion Criteria

• Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of delayed Adverse Events (AEs)	Up to 15 years from last gene-modified (GM) T cell infusion
Persistence of GM T cells	Up to 15 years from last GM T cell infusion
Analysis of vector integration sites	Up to 15 years from last GM T cell infusion
Incidence of replication-competent lentiviruses	Up to 15 years from last GM T cell infusion
Physical growth as assessed by physical examination (pediatric participants only)	Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached
Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)	Up to 15 years from last GM T cells infusion or until Tanner Stage 5
Proportion of participants who progressed on the study: participants with original diagnosis of malignancies	Up to 15 years from last GM T cells infusion
Number of participants with reintroduction of standard treatments for the control of autoimmune disease activity as a surrogate for disease relapse	Up to 15 years from last GM T cells infusion	Participants with autoimmune diseases
Overall Survival (participants with original diagnosis of malignancies)	Up to 15 years from last GM T cells infusion

Secondary Outcome Measures

Name	Time	Method
Lymphocyte count (B-cell)	Up to 15 years	If B-cell recovery criteria are not met at Month 60 (Year 5), then annual monitoring will continue until B-cell recovery is confirmed on 2 consecutive analyses or up to 15 years, until subject withdrawal of consent, or death, whichever occurs first.

Trial Locations

Locations (182)

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Banner MD Anderson Cancer Center; 🇺🇸 Gilbert, Arizona, United States

Mayo Clinic Phoenix; 🇺🇸 Phoenix, Arizona, United States

Arizona Cancer Center; 🇺🇸 Scottsdale, Arizona, United States

Local Institution - 01021; 🇺🇸 Tucson, Arizona, United States

City Of Hope; 🇺🇸 Duarte, California, United States

University Of California San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Local Institution - 01206; 🇺🇸 Los Angeles, California, United States

Local Institution - 01043; 🇺🇸 Sacramento, California, United States

University of California, San Francisco- California; 🇺🇸 San Francisco, California, United States

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