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

NCT00350545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-11-20

Study results available
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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.

Conditions

  • Graft vs Host Disease

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • David Miklos · Stanford University

  • Sally Arai · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-05-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00350545 on ClinicalTrials.gov