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Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
NCT03435796 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- GENETIC Gene-modified (GM) T cell therapy
Study Locations (20)
California
- City Of Hope — Duarte
- University Of California San Diego Moores Cancer Center — La Jolla
- Local Institution - 01206 — Los Angeles
- Local Institution - 01043 — Sacramento
- University of California, San Francisco- California — San Francisco
- UCLA Medical Centre-Santa Monica — Santa Monica
- Stanford Cancer Center — Stanford
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Mayo Clinic Phoenix — Phoenix
- Arizona Cancer Center — Scottsdale
- Local Institution - 01021 — Tucson
Florida
- The Mayo Clinic - Jacksonville, Davis-E — Jacksonville
- Baptist Cancer Center — Miami
- Local Institution - 01035 — Orlando
- H. Lee Moffitt Cancer Center and Research Institute University of South Florida — Tampa
Colorado
- University Of Colorado Cancer Center — Aurora
- Colorado Blood Cancer Institute — Denver
Alabama
- University of Alabama Birmingham — Birmingham
Connecticut
- Yale Cancer Center — New Haven
District of Columbia
- Local Institution - 01050 — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,541 participants |
| Start Date | 2018-07-19 |
| Est. Completion | 2036-11-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03435796
The ClinicalTrials.gov registry entry for NCT03435796 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,541 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention — of which Gene-modified (GM) T cell therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03435796 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03435796 about?
NCT03435796 is a clinical study titled "Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells". 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 o...
What is the current status of trial NCT03435796?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 1,541 participants. The study started on 2018-07-19. Estimated completion is 2036-11-30.
What conditions does trial NCT03435796 study?
This clinical trial studies the following conditions: Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03435796?
The interventions under investigation include: Gene-modified (GM) T cell therapy (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03435796?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03435796 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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