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

Trial Information

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

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 weekly as indicated
until day 100.

- Arm II: Patients receive methylprednisolone or equivalent corticosteroid as in arm I
and placebo.

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
years.