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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

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
NameTimeMethod
Incidence of delayed Adverse Events (AEs)Up to 15 years from last gene-modified (GM) T cell infusion
Persistence of GM T cellsUp to 15 years from last GM T cell infusion
Analysis of vector integration sitesUp to 15 years from last GM T cell infusion
Incidence of replication-competent lentivirusesUp 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 malignanciesUp 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 relapseUp 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
NameTimeMethod
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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University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Luciano Costa, Site 01171
Contact
205-934-9695

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