Phase 3
N=164
Low-Dose Prednisone or Methylprednisolone in Treating Patients With Newly Diagnosed Acute Graft-versus-Host Disease
Graft Versus Host Disease · Recurrent Adult Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00929695 ↗Enrolled (actual)
164
Serious AEs
41.5%
Results posted
Oct 2014
Primary outcome: Primary: Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment — 22.2; 27.1; 38.4; 41.3 milligrams per kilogram — p=0.08
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- prednisone (Drug); methylprednisolone (Drug); questionnaire administration (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Cumulative Prednisone Dose (mg/kg) Over 42 Days From the Start of Treatment |
22.2; 27.1; 38.4; 41.3 | 0.08 |
| SECONDARY Prednisone-associated Toxicity as Assessed by Hyperglycemia |
140; 142 | — |
| SECONDARY Prednisone-associated Toxicity as Assessed by Invasive Infections (Bacterial, Fungal and Viral) |
52; 53 | — |
| SECONDARY Prednisone-associated Toxicity as Assessed by Myopathy |
-0.18; -0.18 | — |
| SECONDARY Prednisone-associated Toxicity as Assessed by Hypertension |
-0.29; -0.24 | — |
| SECONDARY Prednisone-associated Toxicity as Assessed by Quality of Life |
-2.3; -1.9 | — |
| SECONDARY Non-relapse Mortality |
15; 16 | — |
| SECONDARY Recurrent or Progressive Malignancy |
21; 21 | — |
| SECONDARY Progression to Grade III-IV Acute GVHD |
6; 13 | — |
| SECONDARY Secondary Therapy for Acute GVHD Beyond Prednisone |
23; 7 | 0.009 sig |
| SECONDARY Chronic Extensive GVHD |
47; 54 | — |
| SECONDARY Overall Survival |
77; 77 | 0.95 |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00929695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.