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

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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