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
  • AGAVE-201, A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients with Recurrent or Refractory Active Chronic Graft Versus Host Disease who have Received at leas

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2021-006
    NCT ID
    • NCT04710576
    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
    • Joseph
      Uberti, M.D., Ph.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objective
    • To evaluate the overall response rate (ORR) of axatilimab at 0.3 mg/kg Q2W, 1 mg/kg Q2W, and 3 mg/kg Q4W in patients with cGVHD.

    Secondary - Efficacy Objective
    • To evaluate. secondary measures of clinical benefit.

    Secondary - Safety Objectives
    • To evaluate the safety and tolerability of axatilimab in patients with cGVHD
    • Bone morphology

    Secondary - PK/Pharmacodynamic Objectives
    • To assess the plasma population PK (pop PK) profile of axatilimab in patients with cGVHD
    • To assess pharmacodynamic profile of axatilimab
    • To determine or assess the changes in monocyte level with response
    • To determine or assess the baseline in monocyte level with response

    Secondary - Immunogenicity Objective
    • Immunogenicity

  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

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

    Karmanos Cancer Institute at Lawrence and Idell Weisberg Cancer Treatment Center - Farmington Hills

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