Intra Arterial (IA) Steroids Infusion for Hepatic Acute Hepatic Graft Versus Host Disease (aGVHD)
|Acute Graft Versus Host Disease||Drug: Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Hepatic response [ Time Frame: 180 days ]The degree to which serum bilirubin levels do or do not decrease
|Study Start Date:||September 2010|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Drug: Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)
Sedation/anesthesia of patient followed by placement of a 4F vascular sheath and a diagnostic and hepatic angiogram. Angiographic catheter tip to be placed in the proximal proper hepatic artery, secured in place externally and connected to an arterial line pressurized system which allows continuous drip infusion of methylprednisolone diluted in normal saline (600mg/m2 with maximal total dose of 100mg diluted in 480cc in normal saline administered at 20cc/hr for 24 hours).
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140984
|Hadassah Medical Organisation|
|Jerusalem, Israel, 91120|