Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
Purpose
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 GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Condition
- Neoplasms
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored or Celgene alliance partner-sponsored study, 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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Participants exposed to Gene-modified (GM) T cell therapy |
|
Recruiting Locations
UK Center for Clinical and Translational Science and nearby locations
University Of Kentucky
Lexington, Kentucky 40536
Lexington, Kentucky 40536
Contact:
Chaitanya Iragavarapu, Site 01046
Chaitanya Iragavarapu, Site 01046
More Details
- NCT ID
- NCT03435796
- Status
- Recruiting
- Sponsor
- Celgene
Study Contact
BMS Study Connect Contact Center www.BMSStudyConnect.com855-907-3286
Clinical.Trials@bms.com