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

NCT ID: NCT00563108

Last Updated: 2010-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Graft vs Host Disease Hematopoietic Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Basiliximab

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Grade II to IV acute GVHD after SCT

Exclusion Criteria

* Known allergy to basilixmab
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

The Hong Kong Blood Cancer Foundation

OTHER

Sponsor Role collaborator

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Lawrence SY Ma, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine/ Haematology and Oncology, Queen Mary Hospital

Locations

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The University of Hong Kong

Hong Kong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Winnie WW Cheung, Dr

Role: CONTACT

(852) 2855 3111

Other Identifiers

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HARECCTR0500037

Identifier Type: -

Identifier Source: secondary_id

UW 03-312 T312

Identifier Type: -

Identifier Source: org_study_id

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