Studienregister
JCAR017 GC-LTFU-001
Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|
2017-001465-24 |
Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells
Status: Active
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
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)
Responsibilities in overall trial
Sponsor
Celgene Corporation
National Coordinating Investigator
Prof. Dr. med. Peter Borchmann
Study Sites
Klinik I für Innere Medizin
Study office
Klinisches Studienzentrum der Klinik I für Innere Medizin Köln
- Tel. +49 (0)221 478 98888
- Fax +49 (0)221 478 3531
- studien-innere1@uk-koeln.de
Status
Active
Principal Investigator
Prof. Dr. med. Peter Borchmann
Deputy of Principal Investigator
- PD Dr. Dr. med. Udo Holtick
- Priv.-Doz. Dr. med. Bastian von Tresckow
Contact at Site
- Prof. Dr. med. Peter Borchmann
- Tel. +49 221 478-88159
- Fax +49 221 478-88179
- peter.borchmann@uk-koeln.de
- Christina Misch
- Tel. +49 (0)221 478 85489
- Fax +49 (0)221 478 88839
- christina.misch@uk-koeln.de