Neoplasms
Conditions
Keywords
Long-term follow up, Gene-Modified T Cells, CAR T Cell
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.
Interventions
GENETICGene-modified (GM) T cell therapy
No investigational product will be administered
Sponsors
Celgene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delayed Adverse Events (AEs) | Up to 15 years from last gene-modified (GM) T cell infusion |
| Persistence of GM T cell drug products | Up to 15 years from last GM T cell infusion |
| Analysis of vector integration sites | Up to 15 years from last GM T cell infusion |
| Incidence of replication-competent lentiviruses | Up to 15 years from last GM T cell infusion |
| Physical growth as assessed by physical examination (pediatric participants only) | Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached |
| Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only) | Up to 15 years from last GM T cells infusion or until Tanner Stage 5 |
| Proportion of participants who progressed on the study: participants with original diagnosis of malignancies | Up to 15 years from last GM T cells infusion |
| Overall Survival (participants with original diagnosis of malignancies) | Up to 15 years from last GM T cells infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lymphocyte count (B-cell) | Up to 15 years | If B-cell recovery criteria are not met at Month 60 (Year 5), then annual monitoring will continue up to 15 years, until subject withdrawal of consent, or death, whichever occurs first. |
Countries
Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Poland, Romania, South Korea, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed