Intra-Arterial Catheter Directed Therapy for Severe Graft vs. Host Disease (GVHD)
Graft versus host disease (GVHD) is a major complication of allogeneic bone marrow transplantation (BMT), resulting in death in the majority of steroid resistant patients. The study was designed to assess the efficacy of regional intra-arterial treatment in patients with resistant hepatic and/or gastro-intestinal GVHD.
Graft vs Host Disease
Procedure: intra-arterial treatment
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1/2 Study to Evaluate Intra-Arterial Catheter Directed Therapy for Severe Gastro-Intestinal and/or Hepatic Graft vs. Host Disease (GVHD)|
- To assess the efficacy of intra-arterial Methylprednisolone treatment in decreasing the severity of acute GVHD.
- 1. Time to GVHD response. 2. Overall survival. 3. Disease free survival. 4. Acute toxicity.
|Study Start Date:||December 2000|
|Estimated Study Completion Date:||August 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146978
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Michael Y Shapira, MD||Hadassah Medical Organization|