Clinical Studies Search

Protocol Summary


Protocol No.
PSHCI-11-042
Prinicipal Investigator
Rybka, Witold
Phase
NA
Age Group
Both
Scope
National
Secondary Protocol No.
PROTOCOL 10-CBA
Title
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients with Hematologic Malignancies and Other Indications
Objective
Primary Objective:
The primary aim of this study is to examine the incidence of neutrophil recovery of !Y500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not Food and Drug Administration (FDA) licensed.

Secondary Objectives:
In patients receiving a non-licensed CBU:
Assess incidence of graft rejection
Assess incidence of transmission of infection
Assess incidence of serious infusion reaction
Determine 1 year survival after cord blood transplantation
Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
Assess cumulative incidence of chronic GVHD
Determine platelet engraftment of >20,000 mcL and >50,000 mcL
Determine CBU-derived engraftment
Applicable Disease Sites
Other Hematopoietic
Status
Open
Participating Institutions
Hershey Medical Center