Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
Back to Results

  • Long-Term Follow-Up Protocol for Subjects Treated with Gene-Modified T Cells

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2019-106
    NCT ID
    • NCT03435796
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator
    • Image of Abhinav Deol , M.D.
      Abhinav
      Deol, M.D.
      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    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.
    The primary objectives of this study are as follows:
    • 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
    Request an Appointment
    Refer a Patient
    NCI Dictionary of Cancer Terms
    KCI Clinical Trials App
    • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
    Get Directions
    Phone: 1-800-527-6266