Treatment of Acute Graft vs. Host Disease With Steroids Plus Daclizumab (Zenapax) or Placebo
- 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 weekly as indicated
until day 100.
- Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I
Patients are followed at 1 year and then annually thereafter.
PROJECTED ACCRUAL: A total of 166-190 patients will be accrued for this study within 2
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Stephanie J. Lee, MD
Dana-Farber Cancer Institute
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Cancer Institute at Oregon Health and Science University||Portland, Oregon 97201-3098|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Baylor University Medical Center||Dallas, Texas 75246|