Intra Arterial (IA) Steroids Infusion for Hepatic Acute Hepatic Graft Versus Host Disease (aGVHD)

Acute Graft Versus Host Disease Clinical Trial

Official title: An Investigator Initiated Open Study to Evaluate the Efficacy and Safety of Intra Arterial Infusion for Treatment of Steroid Resistant Acute Hepatic Graft Versus Host Disease (AGVHD)

Status Terminated

Clinical Trial Summary

Post allogeneic hematopoietic stem cell transplantation (HSCT) patients with steroid resistant acute GVHD localised to the liver will receive 24 hours continuous intra-arterial infusion of methylprednisolone.

Clinical Trial Description

The study population will include 30 patients with SR AGVHD having an index of B, C, or D on the IBMTR severity index localized to the liver.

Standard treatment for SR AGVHD includes: IV cyclosporine or tacrolimus with adjusted doses depending on serum levels and methylprednisolone or prednisone 2 mg/kg/d. This treatment may be continued during the study period although steroid taper down should be attempted if clinically possible.

GVHD diagnosis will be based upon clinical criteria and biopsy (if needed) from an involved organ. GVHD will be graded according to the International Bone Marrow Transplantation Registry (IBMTR) severity index.

Intra-arterial treatment should be given in less than 72h from completion of inclusion criteria.

Partially responding or non-responding patients may receive a second treatment within 14 days of the initial intra-arterial treatment, at the discretion of the treating physician.

Definitions

Hepatic response:

• Initial response - the day in which bilirubin level began to decrease.

• Partial response 75 - the day in which bilirubin level decreased below 75% of basal level.

• Partial response 50 - the day in which bilirubin level decreased below 50% of basal level.

• Partial response 25 - the day in which bilirubin level decreased below 25% of basal level.

• Complete response - the day in which bilirubin level decreased to normal level. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Graft Versus Host Disease
• Graft vs Host Disease

• NCT number: NCT01140984
• Study type: Interventional
• Source: Hadassah Medical Organization
• Status: Terminated
• Phase: N/A
• Start date: September 2010
• Completion date: March 2015