Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Not Applicable

• Conditions: Graft vs Host Disease; Hematopoietic Stem Cell Transplantation

• Registration Number: NCT00563108
• Lead Sponsor: Hospital Authority, Hong Kong

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-26
• Study Completion: 2008-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-06
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Grade II to IV acute GVHD after SCT

Exclusion Criteria

• Known allergy to basilixmab

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resolution of GVHD by Day 12	12 days

Secondary Outcome Measures

Name	Time	Method
Mortality, GVHD-related and all cause	100 days
Duration and grading of acute GVHD	100 days
Total dose of steroid and immunosuppresant	100 days

Trial Locations

Locations (1)

The University of Hong Kong; 🇨🇳 Hong Kong, China