5-day Defibrotide Treatment for Hepatic SOS/VOD

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Sinusoidal Obstruction Syndrome (SOS), also referred to as hepatic veno-occlusive disease (VOD), is rare but serious complication of allogeneic stem cell transplantation (allo-SCT). Defibrotide is the only FDA approved therapy to treat SOS and has significantly improved outcomes. When applied early, SOS symptoms often quickly improve and an abbreviated course can be applied. This study is looking at an abbreviated 5 day course of defibrotide in those patients with a complete response to therapy with the primary outcome being day 100 overall survival as compared to history data.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Treatments: Defibrotide

Criteria

Inclusion Criteria:

1. Patients who underwent allogeneic stem cell transplantation

2. Age >/= 18 years

3. Diagnosed hepatic SOS/VOD either by Baltimore Criteria or Modified Seattle Criteria including up to 60 days post-transplantation.

Exclusion Criteria:

1. Significant uncontrolled bleeding

2. Prior or concurrent systemic t-PA

3. Concomitant use of therapeutic heparin or other anticoagulants (except use of heparin for central access patency)

4. Hemodynamic instability (>1 pressor gent to maintain blood pressure)