Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Acute graft-versus-host disease post allogeneic stem cell transplantation
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).
Interventions
DRUGBasiliximab
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
The Hong Kong Blood Cancer Foundation
Hospital Authority, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Grade II to IV acute GVHD after SCT
Exclusion criteria
* Known allergy to basilixmab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of GVHD by Day 12 | 12 days |
Secondary
| Measure | Time frame |
|---|---|
| Duration and grading of acute GVHD | 100 days |
| Total dose of steroid and immunosuppresant | 100 days |
| Mortality, GVHD-related and all cause | 100 days |
Countries
China
Contacts
Primary ContactWinnie WW Cheung, Dr
Outcome results
None listed