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  • A Randomized Double-Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma of the Activated B-Cell Subtype

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • A051301
    NCT ID
    • NCT02443077
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator
    • Joseph
      Uberti, M.D., Ph.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objective:

    • To evaluate the ability of ibrutinib to improve 24-month progression free survival (PFS) compared to placebo.

    Secondary Objectives:

    • To evaluate the ability of ibrutinib to improve overall survival (OS) compared to placebo.
    • To evaluate the ability of ibrutinib to improve progression free survival (PFS) compared to placebo.
    • To evaluate the ability of ibrutinib to improve post-transplant response rates compared to placebo.
    • To evaluate time to hematopoietic recovery in the two arms.
    • To evaluate the safety and tolerability of ibrutinib compared to placebo
    • To evaluate the incidence of secondary malignancies in the two arms.
    • To evaluate immune reconstitution in the two arms.
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

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