Purpose / Objectives

Primary Outcome

• To assess the risk of delayed adverse events (AEs) following exposure to GM T cells
• To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate.
• To monitor for generation of replication competent retroviruses (RCR)
• To assess long-term efficacy following treatment with GM T cells
• Describe growth, developmental outcome, and sexual maturity status for subjects who were aged < 18 years at time of GM T cell therapy
• To assess long term health-related quality of life following treatment with GM T cells

Secondary Outcomes

• Per Health Authority guidelines for gene therapy medicinal products that utilize integrating vectors (eg, retroviral vectors), long-term safety and efficacy follow up of treated subjects is required.

Diagnosis

• Non-Hodgkin Lymphoma: B-cell lymphoma

Patient attributes

Age

18-99

Inclusion criteria

• 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 ICF/IAF 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.

Exclusion criteria

Not Applicable

Trial design

• Multicenter
• Prospective

Intervention

Prior treatment with Chimeric Antigen Receptor (CAR) modified T cells or other genetically engineered T cell product, hereafter referred to as gene-modified T cells (GM T cells).

Documents (password protected)

Go to download area

Responsibilities in overall trial

Sponsor

Celgene Corporation

National Coordinating Investigator

Prof. Dr. med. Peter Borchmann

Study Sites