Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Graft Versus Host Disease; Recurrent Adult Acute Lymphoblastic Leukemia
Intervention: prednisone (Drug); methylprednisolone (Drug); questionnaire administration (Other)
Phase: Phase 3
Status: Completed
Sponsored by: Fred Hutchinson Cancer Research Center Official(s) and/or principal investigator(s): Marco Mielcarek, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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
Clinical Details
Official title: A Phase III Study to Determine Efficacy and Safety of Low-Dose Glucocorticoids for Initial Treatment of Acute Graft-versus-Host Disease
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment
Secondary outcome: Prednisone-associated Toxicity as Assessed by HyperglycemiaPrednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral) Prednisone-associated Toxicity as Assessed by Myopathy Prednisone-associated Toxicity as Assessed by Hypertension Prednisone-associated Toxicity as Assessed by Quality of Life Non-relapse Mortality Recurrent or Progressive Malignancy Progression to Grade III-IV Acute GVHD Secondary Therapy for Acute GVHD Beyond Prednisone Chronic Extensive GVHD Overall Survival
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States
Additional Information
Starting date: June 2009
Last updated: March 3, 2015
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