NCT00146978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
Last Updated

November 7, 2006

Status Verified

March 1, 2006

First QC Date

September 4, 2005

Last Update Submit

November 6, 2006

Conditions

Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

intra-arterial treatmentPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Recipient of allogeneic stem cell transplantation. AGVHD of liver and or GI tract, grade 2-4. Resistant AGVHD. Signed a written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (2)

  • 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. doi: 10.1016/s0149-2918(04)90036-7.

    PMID: 15110133RESULT

  • 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. doi: 10.1046/j.1365-2141.2002.03923.x.

    PMID: 12437655RESULT

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Michael Y Shapira, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2005

First Posted

September 7, 2005

Study Start

December 1, 2000

Study Completion

August 1, 2005

Last Updated

November 7, 2006

Record last verified: 2006-03

Locations

IL(1)