- Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells — Recruiting • Phase II • Oncology • NCT03435796.
- What is being tested: Long-term safety and efficacy outcomes in pediatric and adult patients previously treated with gene-modified T-cell therapy through Celgene-sponsored clinical trials, using prospective follow-up monitoring protocols.
- Patient eligibility overview: All participants from prior Celgene-sponsored or alliance partner-sponsored gene-modified T-cell studies are eligible for inclusion in this long-term follow-up protocol, encompassing both paediatric and adult populations.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : * Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, 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.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.