Back to resultsBasiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Primary Purpose
Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Basiliximab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Graft vs Host Disease focused on measuring Acute graft-versus-host disease post allogeneic stem cell transplantation
Eligibility Criteria
Inclusion Criteria:
- Grade II to IV acute GVHD after SCT
Exclusion Criteria:
- Known allergy to basilixmab
Sites / Locations
- The University of Hong KongRecruiting
Outcomes
Primary Outcome Measures
Resolution of GVHD by Day 12
Secondary Outcome Measures
Duration and grading of acute GVHD
Total dose of steroid and immunosuppresant
Mortality, GVHD-related and all cause
Full Information
NCT ID
NCT00563108
First Posted
November 21, 2007
Last Updated
July 6, 2010
Sponsor
Hospital Authority, Hong Kong
Collaborators
Novartis Pharmaceuticals, The Hong Kong Blood Cancer Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00563108
Brief Title
Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital Authority, Hong Kong
Collaborators
Novartis Pharmaceuticals, The Hong Kong Blood Cancer Foundation
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease, Hematopoietic Stem Cell Transplantation
Keywords
Acute graft-versus-host disease post allogeneic stem cell transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Basiliximab
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Resolution of GVHD by Day 12
Time Frame
12 days
Secondary Outcome Measure Information:
Title
Duration and grading of acute GVHD
Time Frame
100 days
Title
Total dose of steroid and immunosuppresant
Time Frame
100 days
Title
Mortality, GVHD-related and all cause
Time Frame
100 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
Grade II to IV acute GVHD after SCT
Exclusion Criteria:
Known allergy to basilixmab
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Winnie WW Cheung, Dr
Phone
(852) 2855 3111
Email
cheungww@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence SY Ma, Dr
Organizational Affiliation
Department of Medicine/ Haematology and Oncology, Queen Mary Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Hong Kong
City
Hong Kong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AYH Leung, Dr
First Name & Middle Initial & Last Name & Degree
Eric Tse, Dr
First Name & Middle Initial & Last Name & Degree
YL Kwong, Prof
First Name & Middle Initial & Last Name & Degree
Raymond Liang, Prof
First Name & Middle Initial & Last Name & Degree
AKW Lie, Dr
First Name & Middle Initial & Last Name & Degree
WY Au, Dr
12. IPD Sharing Statement
Learn more about this trial
Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
We'll reach out to this number within 24 hrs