NCT00929695

Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease

A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This randomized phase III trial is studying low-dose prednisone or methylprednisolone to see how well they work compared with standard-dose prednisone or methylprednisolone in treating patients with newly diagnosed acute graft-versus-host disease (GVHD). Glucocorticoids, such as prednisone or methylprednisolone at a starting dose of 2 mg/kg/day are standard treatment for acute graft-versus-host disease caused by a donor stem cell transplant. It is not yet known whether low-dose glucocorticoids are more effective than standard-dose glucocorticoids in treating acute graft-versus-host-disease

Detailed description

OBJECTIVES: 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 prednisone exposure. 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 thereafter.

Conditions

• Graft Versus Host Disease
• Recurrent Adult Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	prednisone	immunosuppressive drug
DRUG	methylprednisolone	immunosuppressive drug
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2009-06-01
• Primary completion: 2013-07-01
• Completion: 2015-12-14
• First posted: 2009-06-29
• Last updated: 2017-08-21
• Results posted: 2014-10-09

Locations

1 site across 1 country: United States