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

Not Applicable

Terminated

• Conditions: Acute Graft Versus Host Disease
• Interventions: Drug: Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)

• Registration Number: NCT01140984
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-10
• Study Start: 2010-09
• Status Verified: 2011-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-04-19
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Recipient of allogeneic stem cell transplantation.
• Age>18 years.
• Post stem cells transplant <100 days.
• AGVHD of liver, IBMTR index B, C, D.
• Resistant AGVHD - Patients will be eligible for inclusion if they developed grade B-D AGVHD with progression after 3 days standard treatment OR unresponsive to at least 7 days standard treatment OR incomplete response to standard treatment after 14 days.
• Has received no 1st line treatment for steroid refractory AGVHD.
• Signed a written informed consent

Exclusion Criteria

• Not fulfilling any of the inclusion criteria.
• Active life-threatening infection.
• Inability to comply with study requirements.
• Inability to give informed consent.
• Contraindication to arterial catheterization (uncorrectable coagulopathy, severe allergic reaction to contrast material or others).
• Inability to give the first Intra-arterial treatment in less than 72h from completion of inclusion criteria
• An IBMTR index ≤ A.
• Refractory skin AGVHD or severe diarrhea..
• Pregnant or breast-feeding female or childbearing potential.
• Known to be HIV positive.
• Has been diagnosed with veno-occlusive disease.
• Has been diagnosed with multi organ failure.
• Known renal failure eGFR <30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment	Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)	-

Primary Outcome Measures

Name	Time	Method
Hepatic response	180 days	The degree to which serum bilirubin levels do or do not decrease

Trial Locations

Locations (1)

Hadassah Medical Organisation; 🇮🇱 Jerusalem, Israel