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

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society