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
Summary Obj
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.

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