Graft vs Host DiseaseNCT00563108
Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
A study testing Basiliximab 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
Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity and mortality. Steroids remains first line therapy for acute GVHD but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. 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?
- Basiliximab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2004to 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
- Grade II to IV acute GVHD after SCT
Who cannot join
- Known allergy to basilixmab
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong
Hong Kong
AYH Leung, Dr
Eric Tse, Dr
About this study
Official title: A Double-blind Randomized Single-center Trial of Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation.
Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity and mortality. Steroids remains first line therapy for acute GVHD but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and treatment has been described favourably. This is a randomized control trial to investigate its efficacy and safety in the management of acute GVHD post allogeneic stem cell transplantation (SCT).
- Being tested
- Basiliximab, Placebo
- Keywords
- Acute graft-versus-host disease post 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.
BasiliximabDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of GVHD by Day 12
Measured: 12 days
Secondary outcomes (3)
Duration and grading of acute GVHD
Measured: 100 days
Total dose of steroid and immunosuppresant
Measured: 100 days
Mortality, GVHD-related and all cause
Measured: 100 days
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 startJun 2004
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Collaborators
- Novartis Pharmaceuticals, The Hong Kong Blood Cancer Foundation
- Investigators
- Lawrence SY Ma, Dr, Principal investigator, Department of Medicine/ Haematology and Oncology, Queen Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00563108
- Sponsor's protocol ID
- UW 03-312 T312
- Other IDs
- HARECCTR0500037
- 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 Double-blind Randomized Single-center Trial of Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation.
- ClinicalTrials.gov ID
- NCT00563108
- Acronym / sponsor ID
- UW 03-312 T312
- Keywords
- Acute graft-versus-host disease post allogeneic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Collaborators
- Novartis Pharmaceuticals, The Hong Kong Blood Cancer Foundation
- Study start
- Jun 2004
- 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.
Graft-versus-host disease (GVHD) contributes substantially to transplant-related morbidity and mortality. Steroids remains first line therapy for acute GVHD but there is currently no consensus on second line therapy for those in whom steroids have been ineffective. Basiliximab has been shown to be a safe and effective immunosuppresant in the prevention and treatment of rejection after renal transplantation and its role in acute GVHD prophylaxis and treatment has been described favourably. This is a randomized control trial to investigate its efficacy and safety in the management of acute GVHD post allogeneic stem cell transplantation (SCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Grade II to IV acute GVHD after SCT
Key exclusion criteria (1 listed)
- Known allergy to basilixmab
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 |
|---|---|---|
| Basiliximab | Drug | – |
| Placebo | Drug | – |
Primary outcome
Resolution of GVHD by Day 12
Time frame: 12 days
3 secondary outcomes
Duration and grading of acute GVHD
Time frame: 100 days
Total dose of steroid and immunosuppresant
Time frame: 100 days
Mortality, GVHD-related and all cause
Time frame: 100 days
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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Graft vs Host Disease
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 Basiliximab 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?
Resolution of GVHD by Day 12 (time frame: 12 days). 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.