Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
a study on Neoplasms
Summary
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
Summary
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Official Title
LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH CAR T CELLS
Details
Subjects participating in this study will be followed from time of roll-over from the parent GM T protocol until 15 years after the last GMT infusion, withdrawal of consent, lost to follow-up, or death, whichever occurs first. Both local and central laboratory evaluations and safety assessments will be conducted during this trial. In addition, pediatric subjects will be monitored for growth, development and sexual maturity.
Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.
Keywords
Neoplasms Long-term follow up Gene-Modified T Cells CAR T Cell Gene-modified (GM) T cell therapy
Eligibility
You can join if…
Subjects who meet the following criteria will be eligible to participate in the Long-Term
Follow-Up study:
- All adult and pediatric subjects who received at least one GM T cells 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.
- Subject (and, parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
You CAN'T join if...
Not Applicable
Locations
- University of California, San Francisco- California
accepting new patients
San Francisco California 94143 United States - Stanford Cancer Center
not yet accepting patients
Stanford California 94305 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Celgene
- ID
- NCT03435796
- Phase
- Phase 2/3
- Study Type
- Interventional
- Last Updated
Frequently Asked Questions
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03435796.