NCT03435796 · Celgene
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
What this study is about
This is a forward-looking study for the long-term follow-up (LTFU) of safety and effectiveness 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.
View original scientific description
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.
Interventions
GENETIC
Gene-modified (GM) T cell therapy
No investigational product will be administered
Primary outcome measures
Incidence of delayed Adverse Events (AEs)
Time frame: Up to 15 years from last gene-modified (GM) T cell infusion
Persistence of GM T cell drug products
Time frame: Up to 15 years from last GM T cell infusion
Analysis of vector integration sites
Time frame: Up to 15 years from last GM T cell infusion
Incidence of replication-competent lentiviruses
Time frame: Up to 15 years from last GM T cell infusion
Physical growth as assessed by physical examination (pediatric participants only)
Time frame: 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)
Time frame: 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
Time frame: Up to 15 years from last GM T cells infusion
Overall Survival (participants with original diagnosis of malignancies)
Time frame: Up to 15 years from last GM T cells infusion
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Gilbert, Arizona
- Phoenix, Arizona
- Scottsdale, Arizona
- Tucson, Arizona
- Duarte, California
- La Jolla, California
- Los Angeles, California
- Sacramento, California
- San Francisco, California
- Santa Monica, California
- Stanford, California
And 66 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 30, 2026 · Source of record for eligibility and locations