LONG-TERM FOLLOW-UP PROTOCOL FOR SUBJECTS TREATED WITH GENE-MODIFIED T CELLS
Primary Investigator
Ghosh, Monalisa
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT03435796
UM Number
2019.058
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Bone Marrow Transplant
ID (Protocol)
9842
Secondary Protocol No
HUM00162493
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Lymphoid Leukemia
Multiple Myeloma
Non-Hodgkin's Lymphoma
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 GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Eligibility: Inclusion Criteria
• * 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.
• * 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/exclusion criteria apply
For more information about a trial or help finding one, contact the Cancer AnswerLine at 800-865-1125 or [email protected]