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  • A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2024-027
    NCT ID
    • NCT05643638
    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 Joseph Uberti , M.D., Ph.D.
      Joseph
      Uberti, M.D., Ph.D.
      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objective:

    • The primary objective of this study is to assess efficacy of CYP-001 in subjects with HRaGvHD by Overall Response Rate (ORR) at Day 28.

    Secondary Objectives:

    • To assess additional responses and long-term efficacy outcomes
    • To assess Overall Survival (OS)
    • To assess Event-Free survival (EFS)
    • To assess Non-Relapse Mortality (NRM)
    • To assess Failure Free Survival
    • To assess the incidence of Malignancy Relapse/Progression (MR)
    • To measure the incidence of chronic GvHD
    • To assess the cumulative steroid dose until Day 100
    • To evaluate changes in Subject Reported Outcomes
    • To evaluate the safety and tolerability of CYP-001 in subjects with SR-aGvHD
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    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