NCT03435796 Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
| NCT ID | NCT03435796 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Celgene |
| Condition | Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,541 participants |
| Start Date | 2018-07-19 |
| Primary Completion | 2043-05-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 1,541 participants in total. It began in 2018-07-19 with a primary completion date of 2043-05-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: Not Applicable Other protocol-defined inclusion/exclusion criteria apply
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT03435796 clinical trial?
This trial is open to participants of all sexes, studying Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03435796 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03435796 currently recruiting?
Yes, NCT03435796 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT03435796 trial being conducted?
This trial is being conducted at Birmingham, United States, Gilbert, United States, Phoenix, United States, Scottsdale, United States and 11 additional locations.
Who is sponsoring the NCT03435796 clinical trial?
NCT03435796 is sponsored by Celgene. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 1,541 participants.