Status:
COMPLETED
Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Recurrent Adult Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 n...
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...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed acute GVHD (\>= grade IIa) for whom, in the judgment of the attending physician, initial treatment with systemic glucocorticoids is indicated
- Patient or guardian able and willing to provide informed consent
Exclusion
- Hallmarks of chronic GVHD
- GVHD after donor lymphocyte infusion (DLI)
- Patient unwilling to remain in Seattle under the care of the Fred Hutchinson Cancer Research Center (FHCRC)/Seattle Cancer Care Alliance (SCCA) through day 42 after the start of treatment for GVHD
- Uncontrolled infection or other underlying comorbidity (i.e. severe psychiatric illness) that precludes the use of "standard-dose" prednisone
- Recent diagnosis of recurrent or progressive malignancy that precludes the use of "standard-dose" prednisone
- Any prior systemic therapy for acute GVHD (Patients may receive up to 2 doses of low-dose prednisone prior to randomization; low-dose prednisone is defined as 0.5 mg/kg/dose for patients who present with grade IIa GVHD and 1 mg/kg/dose for those who present with grade IIb-IV GVHD)
- Enrollment on Blood and Marrow Transplant Clinical Trials Network (BMT-CTN) trial 0802
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2015
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT00929695
Start Date
June 1 2009
End Date
December 14 2015
Last Update
August 21 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109