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JCAR017 GC-LTFU-001

AcronymISRCTNEudraCTClinicaltrials.govDRKS
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

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

    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