NCT00563108UnknownNot Applicable
A Double-blind Randomized Single-center Trial of Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation.
Hospital Authority, Hong Kong1 site in 1 country60 target enrollmentStarted: June 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Resolution of GVHD by Day 12
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Grade II to IV acute GVHD after SCT
Exclusion Criteria
- •Known allergy to basilixmab
Outcomes
Primary Outcomes
Resolution of GVHD by Day 12
Time Frame: 12 days
Secondary Outcomes
- Duration and grading of acute GVHD(100 days)
- Total dose of steroid and immunosuppresant(100 days)
- Mortality, GVHD-related and all cause(100 days)
Investigators
Study Sites (1)
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