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

Hospital Authority, Hong Kong

Status: Unknown

Conditions: Graft vs Host Disease; Hematopoietic Stem Cell Transplantation

Treatments: Drug: Basiliximab; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00563108

UW 03-312 T312

HARECCTR0500037

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Grade II to IV acute GVHD after SCT

Exclusion criteria

• Known allergy to basilixmab

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind