Neoplasms
Conditions
Interventions
Gene-Modified T cell therapy (No investigational product will be administered in this study)
Sponsors
Hayakawa Jin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
Exclusion criteria
Exclusion criteria: Not Applicable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the risk of delayed adverse events following exposure to GM T cells 2. To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate 3. To monitor for generation of replication-competent lentiviruses 4. To assess long-term efficacy following treatment with GM T cells 5. Describe growth and sexual maturity status for subjects who were aged < 18 years at time of GM T-cell treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To monitor for B-cell levels in subjects who received CD19-directed GM T-cell therapy | — |
Countries
Austria, Belgium, Canada, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactJin Hayakawa
Bristol-Myers Squibb
Outcome results
None listed