A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease
I. To determine whether a lower starting dose of prednisone for treatment of newly diagnosed
acute GVHD results in decreased prednisone exposure without compromising overall survival.
II. To estimate the magnitude of clinical benefit associated with the reduction in
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (Low-dose; prednisone-equivalent dose at initiation of treatment of 0.5 mg/kg/day or
1.0 mg/kg/day; stratified according to initial symptom severity): Patients receive low-dose
prednisone or methylprednisolone once or twice daily in the absence of disease progression
or unacceptable toxicity.
ARM II (Standard-dose; prednisone-equivalent dose at initiation of treatment of 1.0
mg/kg/day or 2.0 mg/kg/day; stratified according to initial symptom severity): Patients
receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 year and then annually
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
>= 33% reduction of cumulative prednisone dose with lower-dose prednisone compared to those given standard-dose prednisone
Demonstrated in a prospective fashion.
At day 42 after initiation of treatment
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|