Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-16-078
Prinicipal Investigator
Greiner, Robert
Phase
Phase III
Age Group
Both
Scope
National
Secondary Protocol No.
15-007
Title
A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant
Objective
The primary objective of the study is to compare the efficacy of defibrotide vs BSC for the prevention of VOD as measured by VOD-free survival by Day +30 post-HSCT in patients who are at high risk or very high risk for developing VOD.

The key secondary objective of the study is to compare the efficacy of defibrotide vs BSC for the prevention of VOD as measured by VOD-free survival by Day +100 post-HSCT in patients who are at high risk or very high risk for developing VOD.
Applicable Disease Sites
Leukemia, other

Lymphoid Leukemia

Myeloid and Monocytic Leukemia
Status
Open
Participating Institutions
Hershey Medical Center