Steroid-Refractory Chronic GVHDPhase 2NCT00472225
Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
A Phase 2 study testing Rituximab in people with Steroid-Refractory Chronic GVHD, run by The Korean Society of Hematopoietic Stem Cell Transplantation at 9 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 74 years
- Conditions the study is for
- Steroid-Refractory Chronic GVHD
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 9 sitesSouth Korea
- Study dates
- May 2007to May 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Busan Baik Hospital
Busan
Busan National University Hospital
Busan
Kyungpook University Hospital
Daegu, Kyungsang-do
Chun Nam National University Hospital
Gwangju
Samsung Medical Center
Seoul, 136-710
Seoul National University
Seoul
Soon Chun Hyang Hospital
Seoul
The Catholic University of Korea
Seoul
Yonsei University Hospital
Seoul
About this study
Official title: Open-Labelled, Multicenter Phase II Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
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.
Read the 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
- Conditions
- Steroid-Refractory Chronic GVHD
- Being tested
- Rituximab
- Keywords
- Chronic graft-versus-host disease, rituximab
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Mabthera
Rituximab Induction: Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks
Rituximab Maintenance: Rituximab 375 mg/m2 monthly IV for 4 consecutive months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rituximab treatment arm Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Within one year after start the first dose of rituximab
Quality of life
Measured: Baseline, the 8th and 52th week.
Toxicity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMay 2007
- Primary completionMay 2008 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-Refractory Chronic GVHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Korean Society of Hematopoietic Stem Cell Transplantation
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Jong-Ho Won, MD, Principal investigator, Soon Chun Hyang Hospital, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00472225
- Sponsor's protocol ID
- KHSCT-01-2007
- Status last verified
- Feb 2009
- First submitted
- 10 May 2007
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Labelled, Multicenter Phase II Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT00472225
- Acronym / sponsor ID
- KHSCT-01-2007
- Conditions
- Steroid-Refractory Chronic GVHD
- Keywords
- Chronic graft-versus-host disease, rituximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The Korean Society of Hematopoietic Stem Cell TransplantationUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- May 2007
- Primary completion
- May 2008 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 11 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RituximabRituximab treatment arm |
Who may qualify
- Ages
- 3 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- 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
- Informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabAlso: MabtheraRituximab Induction: Rituximab 375 mg/m2 weekly IV for 4 consecutive weeks Rituximab Maintenance: Rituximab 375 mg/m2 monthly IV for 4 consecutive months | Drug | 1 |
Primary outcome
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).
3 secondary outcomes
Steroid tapering
Time frame: Within one year after start the first dose of rituximab
Quality of life
Time frame: Baseline, the 8th and 52th week.
Toxicity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
- Home page of the Korean society of hematopoietic stem cell transplantationLink provided by the sponsor.
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cGVHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Ho Won, MD principal investigator
Soon Chun Hyang Hospital, Seoul, Korea
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab in people with Steroid-Refractory Chronic GVHD, run by The Korean Society of Hematopoietic Stem Cell Transplantation at 9 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2009.