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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Novartis Pharmaceuticals
The Hong Kong Blood Cancer Foundation
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00563108
First received: November 21, 2007
Last updated: July 6, 2010
Last verified: July 2010
  Purpose

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 Intervention
Graft vs Host Disease
Hematopoietic Stem Cell Transplantation
Drug: Basiliximab
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Hospital Authority, Hong Kong:

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

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

Estimated Enrollment: 60
Study Start Date: June 2004
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Grade II to IV acute GVHD after SCT

Exclusion Criteria:

  • Known allergy to basilixmab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00563108     History of Changes
Other Study ID Numbers: UW 03-312 T312, HARECCTR0500037
Study First Received: November 21, 2007
Last Updated: July 6, 2010
Health Authority: Hong Kong: Ethics Committee

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
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014