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  • A Phase II Study of Reduced Dose Post Transplantation Cyclophosphamide as GvHD Prophylaxis in Adult Patients with Hematologic Malignancies Receiving HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2023-075
    NCT ID
    • NCT06001385
    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
    • Dipenkumar
      Modi, M.D.

      Oncology - Hematology, Oncology - Medical View Profile


    Primary Objective:

    • To estimate infection-free survival (IFS) and determine safety of combination reduced-dose post-transplantation cyclophosphamide (PTCy), mycophenolate mofetil (MMF), and tacrolimus as graft-versus-host disease (GvHD) prophylaxis for patients with hematologic malignancies receiving mismatched unrelated donor (MMUD) peripheral blood stem cells (PBSC) after myeloablative (MAC) or reduced-intensity conditioning (RIC).

    Secondary Objectives:

    • To determine overall survival (OS), progression-free survival (PFS), Infection-Free Survival (IFS), GvHD relapse free survival (GRFS), non-relapse mortality at 1-year post-HCT.
    • To determine cumulative incidence and kinetics of neutrophil recovery by Day 28.
    • To determine cumulative incidence and kinetics of platelet recovery by Day 180.
    • To determine cumulative incidence of primary and secondary graft failure.
    • To determine donor T-cell chimerism at Day 28, D100 and D365.
    • To determine cumulative incidences of acute GvHD (aGvHD) at Day 100 and D180 and chronic GvHD (cGvHD), at 1-year post HCT.
    • To determine incidence of grade 2-3 bacterial, fungal, and viral at Day 100 and 1-year post HCT (per BMT CTN criteria).
    • To determine cumulative incidence of grades 2-3 BK virus hemorrhagic cystitis at 1-year post-HCT
    • To determine cumulative incidence of relapse/progression at 1-year post HCT.
    • To describe proportion of overall toxicity from initiation of conditioning through 1-year post-HCT
    • To determine incidence and severity of cytokine release syndrome (CRS) within 14 days of HCT.
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