CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 164 enrolled
Drug / intervention
prednisone +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00929695
NCT00929695Phase 3Completed

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

Fred Hutchinson Cancer Center·interventional·Posted Jun 29, 2009·Updated Aug 21, 2017

In Brief

A Phase 3 clinical trial evaluating prednisone, methylprednisolone, and 1 other intervention for Graft Versus Host Disease and Recurrent Adult Acute Lymphoblastic Leukemia. Completed, enrolled 164 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 29, 2009
Enrollment StartJun 1, 2009
Primary CompletionJul 1, 2013
Study CompletionDec 14, 2015
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.0 years ago

Interventions

prednisonedrug

immunosuppressive drug

methylprednisolonedrug

immunosuppressive drug

questionnaire administrationother

Ancillary studies