Graft vs Host DiseaseNCT00563589
Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
A study testing mycophenolate mofetil, methotrexate, cyclosporin and Methotrexate and cyclosporin in people with Graft vs Host Disease and Hematopoietic Stem Cell Transplantation, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
- What is being tested?
- mycophenolate mofetil, methotrexate, cyclosporin and Methotrexate and cyclosporin
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2003to Dec 2008
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling
Who cannot join
- known allergy to mycophenolate mofetil
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
AKW Lie, Dr
WY Au, Dr
About this study
Official title: A Randomized Single-center Trial of Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.
- Being tested
- mycophenolate mofetil, methotrexate, cyclosporin, Methotrexate and cyclosporin
- Keywords
- Acute graft-versus-host disease post high risk allogeneic stem cell transplantation
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycophenolate mofetil, methotrexate, cyclosporinDrug
Methotrexate and cyclosporinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
acute GVHD incidence and grading
Measured: 100 Days
chronic GVHD incidence
Measured: 3 Years
Secondary outcomes (3)
Mortality, GVHD-related and all cause
Measured: 3 Years
Symptomatic side effects attributed to MMF
Measured: 60 Days
Date of engraftment
Measured: Date of engraftment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startAug 2003
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft vs Host DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Hoffmann-La Roche
- Investigators
- Lawrence SY Ma, Dr, Principal investigator, Department of Medicine/ Haematology and Oncology, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563589
- Sponsor's protocol ID
- IRB 03-09 R/353
- Other IDs
- HARECCTR0500036
- Status last verified
- Jul 2010
- First submitted
- 21 Nov 2007
- Last updated
- 7 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-center Trial of Mycophenolate Mofetil for the Prophylaxis of Graft-versus-host Disease in High Risk Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00563589
- Acronym / sponsor ID
- IRB 03-09 R/353
- Keywords
- Acute graft-versus-host disease post high risk allogeneic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Hoffmann-La Roche
- Study start
- Aug 2003
- Study completion
- Dec 2008 (estimated)
- First posted
- 26 Nov 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.
There is a significant (50-80%) risk of acute graft-versus-host disease(GVHD) and early mortality (30%) associated with high risk stem cell transplantation (SCT) such as that from a matched unrelated donor or HLA-mismatch sibling. Mycophenolate mofetil (MMF) has been shown to be an effective and safe immunosuppressant in the prevention and treatment of rejection after solid organ transplantation. Its role in acute GVHD prophylaxis in high risk SCT will be investigated in this clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing allogeneic SCT with high risk of acute GVHD, ie. from matched unrelated donor or one HLA-locus mismatch sibling
Key exclusion criteria (1 listed)
- known allergy to mycophenolate mofetil
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 |
|---|---|---|
| mycophenolate mofetil, methotrexate, cyclosporin | Drug | – |
| Methotrexate and cyclosporin | Drug | – |
Primary outcome
acute GVHD incidence and grading
Time frame: 100 Days
chronic GVHD incidence
Time frame: 3 Years
3 secondary outcomes
Mortality, GVHD-related and all cause
Time frame: 3 Years
Symptomatic side effects attributed to MMF
Time frame: 60 Days
Date of engraftment
Time frame: Date of engraftment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
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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.
Lawrence SY Ma, Dr principal investigator
Department of Medicine/ Haematology and Oncology, Queen Mary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mycophenolate mofetil, methotrexate, cyclosporin and Methotrexate and cyclosporin in people with Graft vs Host Disease and Hematopoietic Stem Cell Transplantation, run by Hospital Authority, Hong Kong at 1 site in China.
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 1 inclusion and 1 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 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
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?
Contact Winnie WW Cheung, Dr ((852) 2855 3111, cheungww@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute GVHD incidence and grading (time frame: 100 Days). The study lists 2 primary outcomes in all. 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 7 Jul 2010.