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.
Stage 5 per Tanner Staging Criteria must be reached prior to study discontinuation.
Accepting Healthy Volunteers?
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.