At a glance
ClinicalIndex Comparison RecordN/ACompleted· 37 enrolled
Drug / intervention
Rituximab +3 moredrug
Likely dose
Rituximab 375 mg/m2from 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.
A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease
In Brief
A clinical study evaluating Rituximab, Prednisone, and 2 other interventions for Graft vs Host Disease. Completed, enrolled 37 participants across 1 site.
Detailed Summary
The addition of rituximab to prednisone for the initial treatment of chronic GVHD will increase the overall response rate, enable a more rapid and effective steroid taper.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGraft vs Host Disease
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2006
Enrollment StartAug 2006
Primary CompletionMay 2012
Study CompletionOct 2014
TodayJul 2026
First PostedJul 10, 2006
Enrollment StartAug 1, 2006
Primary CompletionMay 1, 2012
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.0 years ago
Interventions
Rituximabdrug
375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9
Prednisonedrug
1 mg/kg; po per day with taper
Cyclosporine Adrug
trough 200-300 or lower; po
tacrolimusdrug
trough 5-10 or lower; po