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

Status
Active
Cancer Type
Multiple Primaries
Trial Phase
Eligibility
Any age, Male and Female
Study Type
Supportive care
NCD ID
NCT01351545
Protocol IDs
10-CBA (primary)
Study Sponsor
Medical College of Wisconsin Cancer Center

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 aim 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 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

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
404-851-8238

Doctors:

Asad Bashey MD, PhD
H. Kent Holland MD
Lawrence E. Morris, Jr. MD
Scott R. Solomon MD