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  • Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2022-061
    NCT ID
    • NCT05041309
    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:

    Primary Objectives:

    • Evaluate the incidence and severity of late-onset targeted adverse events (AEs)/serious adverse events (SAEs) suspected to be possibly related to gene-modified cells, including neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies
    • Evaluate mechanism of replication-competent retrovirus/replication-competent lentivirus (RCR/RCL) and/or insertional mutagenesis for confirmed events related to the cell therapy product
    • Evaluate the growth, development, and sexual maturity of
      pediatric and adolescent subjects treated with
      gene-modified cells

    Secondary Objectives:

    • Determine the time to next treatment after administration of gene-modified cell therapy in the completed parent study
    • Determine survival status
    • Determine cause of death
    • Evaluate immune reconstitution
    • Evaluate the incidence of RCR/RCL
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    • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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