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Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease

NCT00472225 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2009-02-24

No results posted yet for this study

Summary

Chronic GVHD is the most common late complication following allogeneic stem cell transplantation. It has features resembling autoimmune disorders such as scleroderma, primary biliary cirrhosis, bronchiolitis obliterans, chronic immunodeficiency etc. Thus, chronic GVHD can lead to debilitating complications such as joint contractures, blindness, end-stage lung disease, etc so that chronic GVHD has a major impact both on survival as well as quality of life. Although its pathogenesis is still poorly unclear, it has been reported since 2000 that B cell-mediated immunity may also contribute to development of chronic GVHD other than T cells. Thus, targeting against B cell may be a useful treatment strategy in the treatment of chronic GVHD.

The purpose of this study is to determine whether rituximab, an anti-CD20 monoclonal kimeric antibody is effective in the treatment of chronic graft-versus-host disease (chronic GVHD) refractory to steroid.

Conditions

  • Steroid-Refractory Chronic GVHD

Interventions

DRUG

Rituximab

Rituximab Induction: Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks Rituximab Maintenance: Rituximab 375 mg/m2 monthly IV for 4 consecutive months

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • The Korean Society of Hematopoietic Stem Cell Transplantation

    lead OTHER

Principal Investigators

  • Jong-Ho Won, MD · Soon Chun Hyang Hospital, Seoul, Korea

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-05-31
Completion
2009-05-31

Countries

  • South Korea

Study Locations

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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 NCT00472225 on ClinicalTrials.gov