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NCT00563108 Clinical Trial

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

Graft vs Host Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00563108
Other study ID # UW 03-312 T312
Secondary ID HARECCTR0500037
Status Recruiting
Phase N/A
First received November 21, 2007
Last updated July 6, 2010
Start date June 2004
Est. completion date December 2008

Study information
Verified date July 2010
Source Hospital Authority, Hong Kong
Contact Winnie WW Cheung, Dr
Phone (852) 2855 3111
Email cheungww@hotmail.com
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Grade II to IV acute GVHD after SCT

Exclusion Criteria:

- Known allergy to basilixmab

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Basiliximab

• Placebo

Locations
Country Name City State
China The University of Hong Kong Hong Kong

Sponsors (3)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong Novartis Pharmaceuticals, The Hong Kong Blood Cancer Foundation

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resolution of GVHD by Day 12 12 days
Secondary Duration and grading of acute GVHD 100 days
Secondary Total dose of steroid and immunosuppresant 100 days
Secondary Mortality, GVHD-related and all cause 100 days
See also
  Status Clinical Trial Phase
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Recruiting NCT01764100 - Mesenchymal Stromal Cells (MSCs) for the Treatment of Graft Versus Host Disease (GVHD) Phase 1
Completed NCT00760981 - A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease Phase 1
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Completed NCT02841995 - A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease Phase 2
Recruiting NCT06143501 - Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT
Recruiting NCT04622956 - GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide Phase 1/Phase 2
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Not yet recruiting NCT06450925 - Vitamin A Supplementation in Allogeneic Stem Cell Transplantation. N/A
Not yet recruiting NCT02506231 - The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome Phase 2/Phase 3
Recruiting NCT01042509 - Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease N/A

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