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

Primary Purpose

Steroid-Refractory Chronic GVHD

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rituximab
Sponsored by
The Korean Society of Hematopoietic Stem Cell Transplantation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Steroid-Refractory Chronic GVHD focused on measuring Chronic graft-versus-host disease, rituximab

Eligibility Criteria

3 Years - 74 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Kyungpook University Hospital
  • Busan Baik Hospital
  • Busan National University Hospital
  • Chun Nam National University Hospital
  • Samsung Medical Center
  • Seoul National University
  • Soon Chun Hyang Hospital
  • The Catholic University of Korea
  • Yonsei University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Rituximab treatment arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Steroid tapering
Quality of life
Toxicity

Full Information

First Posted
May 10, 2007
Last Updated
February 20, 2009
Sponsor
The Korean Society of Hematopoietic Stem Cell Transplantation
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00472225
Brief Title
Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
Official Title
Open-Labelled, Multicenter Phase II Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2008 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The Korean Society of Hematopoietic Stem Cell Transplantation
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
STUDY OBJECTIVES Primary Endpoints: To assess the response rate Secondary End points To evaluate the discontinuation of corticosteroid To assess the quality of life Treatment schedule The BSA on the date of every treatment cycle may be used as the same value of baseline BSA, if change of body weight is within 10% of baseline body weight. Treatment schedule consists of induction and maintenance therapy as follows Induction - Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks Maintenance - Rituximab 375 mg/m2 monthly IV for 4 consecutive months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Steroid-Refractory Chronic GVHD
Keywords
Chronic graft-versus-host disease, rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Rituximab treatment arm
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera
Intervention Description
Rituximab Induction: Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks Rituximab Maintenance: Rituximab 375 mg/m2 monthly IV for 4 consecutive months
Primary Outcome Measure Information:
Title
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
Time Frame
Response evaluation will be perfomed every 4 weeks during the maintenance of rituximab (the 12th, 16th, 20th, 24st, 36th and 52th week).
Secondary Outcome Measure Information:
Title
Steroid tapering
Time Frame
Within one year after start the first dose of rituximab
Title
Quality of life
Time Frame
Baseline, the 8th and 52th week.
Title
Toxicity
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong-Ho Won, MD
Organizational Affiliation
Soon Chun Hyang Hospital, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyungpook University Hospital
City
Daegu
State/Province
Kyungsang-do
Country
Korea, Republic of
Facility Name
Busan Baik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Busan National University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Chun Nam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
136-710
Country
Korea, Republic of
Facility Name
Seoul National University
City
Seoul
Country
Korea, Republic of
Facility Name
Soon Chun Hyang Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
http://www.bmt.or.kr
Description
Home page of the Korean society of hematopoietic stem cell transplantation

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

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