GA NCORP

NCORP Trials

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

Status
Active
Cancer Type
Hematopoietic Malignancies
Trial Phase
Eligibility
0 Years and older, Male and Female
Study Type
Other
NCD ID
NCT01351545
Protocol IDs
10-CBA (primary)
Study Sponsor
Center for International Blood and Marrow Transplant Research

Summary

This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.

Objectives

Principal Investigators:

The principal investigators (PIs) will be transplant physicians at all participating U.S.
transplant centers.

Study Design:

This study is an access and distribution protocol for unlicensed cryopreserved cord blood
units (CBUs) in pediatric and adult patients with hematologic malignancies and other
indications.

Primary Objective:

The primary objective of this study is to examine the incidence of neutrophil recovery of
=500/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 transmission of infection

- Assess incidence of serious infusion reaction

- Determine 1 year overall 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

Treatment Sites


Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com

Study Coordinator:
Stacey Brown
404-780-7965

Doctors:

Asad Bashey MD, PhD
H. Kent Holland MD
Lawrence E. Morris, Jr. MD
Scott R. Solomon MD
 
For a complete listing of all trial sites in Georgia, please visit GeorgiaCancerInfo.org