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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00146978
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : November 7, 2006
Information provided by:
Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment Phase
Graft vs Host Disease Procedure: intra-arterial treatment Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : December 2000
Estimated Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To assess the efficacy of intra-arterial Methylprednisolone treatment in decreasing the severity of acute GVHD.

Secondary Outcome Measures :
  1. 1. Time to GVHD response. 2. Overall survival. 3. Disease free survival. 4. Acute toxicity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146978

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