Intra-Arterial Catheter Directed Therapy for Severe Graft vs. Host Disease (GVHD) - Full Text View

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00146978

Purpose

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.

Condition	Intervention	Phase
Graft vs Host Disease	Procedure: intra-arterial treatment	Phase I Phase II

Study Type:	Interventional
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)

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

To assess the efficacy of intra-arterial Methylprednisolone treatment in decreasing the severity of acute GVHD.

Secondary Outcome Measures:

1. Time to GVHD response. 2. Overall survival. 3. Disease free survival. 4. Acute toxicity.

Estimated Enrollment:	50
Study Start Date:	December 2000
Estimated Study Completion Date:	August 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Recipient of allogeneic stem cell transplantation. AGVHD of liver and or GI tract, grade 2-4. Resistant 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. Contraindication to arterial catheterization. Has been diagnosed with multi organ failure.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146978

Locations

Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:

Michael Y Shapira, MD

Hadassah Medical Organization

More Information

Publications:

Bloom AI, Shapira MY, Or R, Sasson T, Resnick IB, Zilberman I, Verstandig A, Aker M, Slavin S, Muszkat M. Intrahepatic arterial administration of low-dose methotrexate in patients with severe hepatic graft-versus-host disease: an open-label, uncontrolled trial. Clin Ther. 2004 Mar;26(3):407-14.

Shapira MY, Bloom AI, Or R, Sasson T, Nagler A, Resnick IB, Aker M, Zilberman I, Slavin S, Verstanding A. Intra-arterial catheter directed therapy for severe graft-versus-host disease. Br J Haematol. 2002 Dec;119(3):760-4.

ClinicalTrials.gov Identifier:	NCT00146978 History of Changes
Other Study ID Numbers:	903/11/0-HMO-CTIL
Study First Received:	September 4, 2005
Last Updated:	November 6, 2006
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:

Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012