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

This study has been completed.
Information provided by:
Hadassah Medical Organization Identifier:
First received: September 4, 2005
Last updated: November 6, 2006
Last verified: March 2006

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 1
Phase 2

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)

Resource links provided by NLM:

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


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

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
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Please refer to this study by its identifier: NCT00146978

Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Michael Y Shapira, MD Hadassah Medical Organization
  More Information

Publications: 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 processed this record on October 08, 2015