Clinical Trial: Methylprednisolone With or Without Daclizumab in Treating Patients With Acute Graft-Versus-Host Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo

Brief Summary:

The purpose of this study is to compare the effects of IL2 receptor antibody (also known as Daclizumab or Zenapax) and corticosteroids alone for control of GVHD. Treatment with corticosteroids is standard care for GVHD. This research is being done because the investigators do not know whether addition of this new medication to standard corticosteroid therapy improves response rates. Since Zenapax binds to a type of cell which is thought to cause GVHD and possibly inactivates them, investigators have reason to believe that addition of Zenapax night result in better control of GVHD This study will determine whether the addition of another medication, Zenapax, will be more effective than steroids alone in suppressing GVHD and improving symptoms of GVHD.

Daclizumab (Zenapax) is approved by the Food and Drug Administration (FDA) for use in patient with kidney transplant to help prevent graft rejection. This medication has been used in bone marrow transplant patients to treat GVHD.


Detailed Summary:

GVHD occurs when the donor's immune system recognizes a patient's body as foreign and reacts against it. GVHD may result in skin rashes and blistering, liver inflammation and gastrointestinal problems including nausea, vomiting, diarrhea and bleeding. Mild GVHD may be treated with topical medications applied to the skin. More severe GVHD requires medications given intravenously (by vein) or taken by mouth. Steroids are usually given first to treat GVHD but only 40% of people respond to this alone.

OBJECTIVES:

  • Compare response to treatment in patients with acute graft-versus-host disease (GVHD) treated with methylprednisolone with or without daclizumab.
  • Compare differences in total methylprednisolone dose and complications in patients treated with these regimens.
  • Compare mortality, days of antibiotics and antifungal therapy, and required hospital days within the first 100 days for patients treated with these regimens.
  • Compare overall survival and incidence of chronic GVHD at 1 year in patients treated with these regimens.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to prior graft-versus-host disease (GVHD) prophylaxis (immunosuppressive therapy vs T-cell depletion), GVHD organ manifestation (skin only vs other), donor type (6/6 matched sibling vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive methylprednisolone or equivalent corticosteroid IV or orally and daclizumab IV over 15 minutes on days 0, 3, 7, 14, and then weekl
    Sponsor: Dana-Farber Cancer Institute

    Current Primary Outcome: Rate of decrease of acute GVHD grade [ Time Frame: Day 42 ]

    Original Primary Outcome:

    Current Secondary Outcome:

    • 100 Day Mortality [ Time Frame: 100 Day ]
    • Complete Response of GVHD [ Time Frame: 100 Days ]
    • Total Days of Antibiotic or Antifungal [ Time Frame: 100 Days ]
    • Number of Hospitalized Days [ Time Frame: 100 Days ]
    • Total Steroid Dose [ Time Frame: 100 Days ]
    • Number of Participants with Steroid related Complication [ Time Frame: 1 Year ]
    • Overall Survival [ Time Frame: 100 Days ]
    • Relapse Rate [ Time Frame: 1 Years ]


    Original Secondary Outcome:

    Information By: Dana-Farber Cancer Institute

    Dates:
    Date Received: February 5, 2003
    Date Started: January 2001
    Date Completion:
    Last Updated: January 19, 2017
    Last Verified: January 2017