An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

Official Title

A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopietic Stem Cell Transplant

Summary:

This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

Trial Description

Primary Outcome Measures :

• Cumulative Incidence of Grade B-D aGvHD by Day +100 post-allogeneic HSCT

Secondary Outcome Measures :

• Grade B-D aGvHD-free survival by Days +100 and +180 post-HSCT
• Cumulative Incidence of Grade B-D aGvHD by Day +180 post-HSCT
• Cumulative Incidence of Grade C-D aGvHD by Days +100 and +180 post-HSCT
• Cumulative Incidence of Relapse by Days +100 and +180 post-HSCT
• Incidence of Systemic Steroid Use in the Treatment of aGvHD by Day +180 post-HSCT
• Health-related Quality of Life (HRQoL) as Measured by Functional Assessment of Cancer Therapy-Bone Marrow Transplant-Trial Outcomes Index (FACT-BMT-TOI)
• HRQoL as Measured by EuroQOL-5D (EQ-5D)

View this trial on ClinicalTrials.gov