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.