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

NCT00472225 | Unknown Phase 2 DMC

• 1 other identifier: KHSCT-01-2007
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

Chronic graft-versus-host disease; rituximab

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) : Resolution of all signs and symptoms of chronic GVHD Partial response (PR) : Improvement (at least 1 clinical score reduction) in 1 or more organs of involvement and no evidence of worsening in any organ

  Response evaluation will be perfomed every 4 weeks during the maintenance of rituximab (the 12th, 16th, 20th, 24st, 36th and 52th week).

Secondary Outcomes (3)

• Steroid tapering

  Within one year after start the first dose of rituximab

• Quality of life

  Baseline, the 8th and 52th week.

• Toxicity

  1 year

Study Arms (1)

1

EXPERIMENTAL

Rituximab treatment arm

Drug: Rituximab

Interventions

Rituximab DRUG

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

Also known as: Mabthera

1

Eligibility Criteria

• Age: 3 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All recipients underwent allogeneic stem cell transplantation for haematologic disorders
• All recipients diagnosed as chronic GVHD according to diagnostic criteria proposed by National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD
• The presence of one diagnostic sign Or
• The presence of one distinctive sign (Appendix 1B) with laboratory or histopathologic confirmation in the same or other organ if diagnostic feature is not present
• All patients with chronic GVHD have at least moderate score based on the global scoring system of chronic GVHD
• Recipients refractory or resistant to therapy with corticosteroid
• Patients had chronic GVHD with the same severity during the last one month while they had received the equivalent of prednisone ≥0.5mg/kg per day or 1mg/kg every other day at least for 30 days or longer
• Informed consent
• Other concomitant medication
• Patients treated with other immunosuppressive agents (cyclosporine, thalidomide etc) as a combination therapy with corticosteroid must be receiving a dosage that has been stable for at least 1 month prior to screening.

You may not qualify if:

• Recipients received donor lymphocyte infusions in the preceding 100 days
• Serious comorbid diseases
• Life expectancy of less than 1 month
• Age \< 2 years and \> 75 years
• Pregnant or intended to become pregnant
• Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

Sponsors & Collaborators

• The Korean Society of Hematopoietic Stem Cell Transplantation: lead
• Hoffmann-La Roche: collaborator

Study Sites (9)

Kyungpook University Hospital

Daegu, Kyungsang-do, South Korea

Location

Busan Baik Hospital

Busan, South Korea

Location

Busan National University Hospital

Busan, South Korea

Location

Chun Nam National University Hospital

Gwangju, South Korea

Location

Samsung Medical Center

Seoul, 136-710, South Korea

Location

Seoul National University

Seoul, South Korea

Location

Soon Chun Hyang Hospital

Seoul, South Korea

Location

The Catholic University of Korea

Seoul, South Korea

Location

Yonsei University Hospital

Seoul, South Korea

Location

Related Links

• Home page of the Korean society of hematopoietic stem cell transplantation

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jong-Ho Won, MD

  Soon Chun Hyang Hospital, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: May 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2009
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

KR (9)