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
  • A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel Concomittant with Prophylactic Steroids in Subjects with Relapsed or Refractory Large B-Cell Lymphoma in the Outpatient Setting

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2022-058
    NCT ID
    • NCT05459571
    Age Group
    • Adult
    • 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
    • Abhinav
      Deol, M.D.

      Oncology - Hematology, Oncology - Medical View Profile


    Primary Objectives

    • Evaluate the rate and severity of cytokine release syndrome (CRS) and neurologic events following outpatient administration of axicabtagene ciloleucel

    Secondary Objectives

    • Characterization of the expanded safety profile including, time to onset and duration of CRS/neurologic events, patterns of hospitalization, incidence and duration of infections/cytopenias
    • Change in the European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) over time.;
    • Assessment of clinical efficacy
    • Assessment of pharmacokinetics and pharmacodynamics, including the levels of anti-CD19 chimeric antigen receptor (CAR) T-cells and serum proinflammatory, immuno-modulatory and effector molecules.

    Exploratory Objectives:

    • Explore the pattern of worsening of CRS and neurologic events following axicabtagene ciloleucel administration (ie, time from Grade 1 to Grade 2)
    • Exploration of the utility of electronic wearable technology in outpatient monitoring and assessment of predictive modeling for outpatient selection for axicabtagene ciloleucel treatment
    • Assessment of T-cell immunogenicity against the CAR
  • Locations


    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

    31995 Northwestern Hwy
    Farmington Hills, MI 48334
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    Phone: 800-527-6266