Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
- 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
- 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.
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
Scroll for more (172 remaining)University of Alabama Birmingham🇺🇸Birmingham, Alabama, United StatesLuciano Costa, Site 01171Contact205-934-9695