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

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ClinicalTrials.gov Identifier: NCT00563108
Recruitment Status : Unknown
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was:  Recruiting
First Posted : November 26, 2007
Last Update Posted : July 7, 2010
Sponsor:
Collaborators:
Novartis Pharmaceuticals
The Hong Kong Blood Cancer Foundation
Information provided by:
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).

Condition or disease Intervention/treatment
Graft vs Host Disease Hematopoietic Stem Cell Transplantation Drug: Basiliximab Drug: Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : June 2004
Estimated Study Completion Date : December 2008





Primary Outcome Measures :
  1. Resolution of GVHD by Day 12 [ Time Frame: 12 days ]

Secondary Outcome Measures :
  1. Duration and grading of acute GVHD [ Time Frame: 100 days ]
  2. Total dose of steroid and immunosuppresant [ Time Frame: 100 days ]
  3. Mortality, GVHD-related and all cause [ Time Frame: 100 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Grade II to IV acute GVHD after SCT

Exclusion Criteria:

  • Known allergy to basilixmab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00563108


Contacts
Contact: Winnie WW Cheung, Dr (852) 2855 3111 cheungww@hotmail.com

Locations
China
The University of Hong Kong Recruiting
Hong Kong, China
Sub-Investigator: AYH Leung, Dr         
Sub-Investigator: Eric Tse, Dr         
Sub-Investigator: YL Kwong, Prof         
Sub-Investigator: Raymond Liang, Prof         
Sub-Investigator: AKW Lie, Dr         
Sub-Investigator: WY Au, Dr         
Sponsors and Collaborators
Hospital Authority, Hong Kong
Novartis Pharmaceuticals
The Hong Kong Blood Cancer Foundation
Investigators
Principal Investigator: Lawrence SY Ma, Dr Department of Medicine/ Haematology and Oncology, Queen Mary Hospital

Additional Information:
ClinicalTrials.gov Identifier: NCT00563108     History of Changes
Other Study ID Numbers: UW 03-312 T312
HARECCTR0500037
First Posted: November 26, 2007    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Hospital Authority, Hong Kong:
Acute graft-versus-host disease post allogeneic stem cell transplantation

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Basiliximab
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs