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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
NCT 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

Eligibility

  1. Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
  2. Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
  3. Pediatric and adult patients of any age

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

Study Coordinator:
Sindy Midoro

Doctors:

Kuang-Yueh Chiang MD, PhD
Ann E. Haight MD
John T. Horan MD, MPH
Muna Qayed MD

Aflac Cancer and Blood Disorders Center of Children’s at Scottish Rite


5455 Meridian Mark Road
Suite 400
Atlanta, GA 30342
404-785-2215
www.choa.org

Study Coordinator:
Sindy Midoro

Doctors:

Kuang-Yueh Chiang MD, PhD
Ann E. Haight MD
John T. Horan MD, MPH

Northside Hospital Cancer Institute


1000 Johnson Ferry Road NE
Atlanta, GA 30342
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
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