NCT00350545

A Phase 2 Trial of Rituximab and Corticosteroid Therapy for Newly Diagnosed Chronic Graft Versus Host Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 1 Year – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To determine the efficacy of Rituximab as first line of treatment of chronic GVHD. Efficacy will be defined as he ability to taper prednisone to a dose of 0.25 mg/kg per day by 6 months without clinical or GVHD relapse/ recurrence.

Conditions

• Graft vs Host Disease

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m2;IV infusion once weekly for four doses (days 1,8,15,22); option for second 4-week course at week 9
DRUG	Prednisone	1 mg/kg; po per day with taper
DRUG	Cyclosporine A	trough 200-300 or lower; po
DRUG	tacrolimus	trough 5-10 or lower; po

Timeline

• Start date: 2006-08-01
• Primary completion: 2012-05-01
• Completion: 2014-10-01
• First posted: 2006-07-10
• Last updated: 2017-11-20
• Results posted: 2017-11-20

Locations

1 site across 1 country: United States