Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
- Interventional
- Recruiting
- NCT03435796
Contact Information
LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH CAR T CELLS
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.
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.
Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.
Gender
All
Age Group
Any
Accepting Healthy Volunteers?
No
Inclusion Criteria:
Subjects who meet the following criteria will be eligible to participate in the Long-Term Follow-Up study:
1. 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.
2. 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.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
Not Applicable
Subjects who meet the following criteria will be eligible to participate in the Long-Term Follow-Up study:
1. 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.
2. 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.
3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
Not Applicable