NCT00563108

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

First QC Date

November 21, 2007

Last Update Submit

July 6, 2010

Conditions

Graft vs Host DiseaseHematopoietic Stem Cell Transplantation

Keywords

Acute graft-versus-host disease post allogeneic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • Resolution of GVHD by Day 12

    12 days

Secondary Outcomes (3)

  • Duration and grading of acute GVHD

    100 days

  • Total dose of steroid and immunosuppresant

    100 days

  • Mortality, GVHD-related and all cause

    100 days

Interventions

BasiliximabDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Grade II to IV acute GVHD after SCT

You may not qualify if:

  • Known allergy to basilixmab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Basiliximab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lawrence SY Ma, Dr

    Department of Medicine/ Haematology and Oncology, Queen Mary Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Winnie WW Cheung, Dr

CONTACT

(852) 2855 3111cheungww@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 21, 2007

First Posted

November 26, 2007

Study Start

June 1, 2004

Study Completion

December 1, 2008

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

CN(1)