A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
NCT ID: NCT01351545
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
99999 participants
OBSERVATIONAL
2011-10-31
2041-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Unlicensed CBU
The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
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
Interventions
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A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
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
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age
Exclusion Criteria
* Cord blood transplant recipients at international transplant centers
* Patients who are enrolled on another IND protocol to access the unlicensed CBU(s)
* Patients whose selected unlicensed CBU(s) will be more than minimally manipulated
ALL
No
Sponsors
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National Marrow Donor Program
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK
Responsible Party
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Principal Investigators
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Heather Stefanski, MD, PhD
Role: STUDY_CHAIR
NMDP/CIBMTR
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Mayo Clinic Arizona (adults)
Phoenix, Arizona, United States
University of Arizona Medical Center - Tucson
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Children's Hospital of Los Angeles
Glendale, California, United States
Scripps Green Hospital
La Jolla, California, United States
University of California San Diego
La Jolla, California, United States
Loma Linda University Cancer Center
Loma Linda, California, United States
UCLA
Los Angeles, California, United States
Children's Hospital and Research Center of Oakland
Oakland, California, United States
Children's Hospital of Orange County (CHOC)
Orange, California, United States
Sutter Medical Center
Sacramento, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
UCSF (adults)
San Francisco, California, United States
UCSF (Peds)
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of Colorado Hospital
Aurora, Colorado, United States
Presbyterian St. Luke's/Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Nemours - Alfred I. duPont Hospital for Children
Brandywine, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Florida Shands Medical Center
Gainesville, Florida, United States
Nemours Children's Hospital - Mayo Jacksonville
Jacksonville, Florida, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of Miami (adult)
Miami, Florida, United States
University of Miami (peds)
Miami, Florida, United States
Niklaus Children's Hospital
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Florida Center for Pediatric Cellular Therapy
Orlando, Florida, United States
Orlando Health Arnold Palmer Hospital for Children
Orlando, Florida, United States
Orlando Health Cancer Institute Bone Marrow Transplant and Cellular Therapy
Orlando, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
H Lee Moffitt Cancer Center
Tampa, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University Health
Augusta, Georgia, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Midwestern Regional Medical Center
Zion, Illinois, United States
Indiana Blood & Marrow Transplantation
Beech Grove, Indiana, United States
Indiana University/Riley Hospital for Children
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas
Westwood, Kansas, United States
University of Louisville Hospital - James Brown Cancer Center
Louisville, Kentucky, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Children's Hospital of New Orleans/LSUHSC
New Orleans, Louisiana, United States
Greenebaum Cancer Center - University of Maryland
Baltimore, Maryland, United States
Johns Hopkins
Baltimore, Maryland, United States
Nih/Niaid
Bethesda, Maryland, United States
NIH/NCI
Bethesda, Maryland, United States
Nih/Nhlbi
Bethesda, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Univeristy of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
St. Louis University Medical Center
St Louis, Missouri, United States
Washington University St. Louis
St Louis, Missouri, United States
Washington University/St. Louis Children's Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Robert Wood Johnson/Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
North Shore University Hospital
Lake Sucess, New York, United States
Cohen Children's Medical Center of New York
New Hyde, New York, United States
New York University Langone Medical Center
New York, New York, United States
New York Presbyterian Hospital at Cornell
New York, New York, United States
Mount Sinai Medical Center - New York
New York, New York, United States
Columbia University Medical Center - Morgan Stanley Children's Hospital
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Westchester Medical Center
New York, New York, United States
Strong Memorial Hospital/University of Rochester
Rochester, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Childrens Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
The Jewish Hospital
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Arthur G. James Cancer Hospital/The Ohio State University Medical Center
Columbus, Ohio, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University/Doernbecher Children's Hospital
Portland, Oregon, United States
Penn State Milton S. Hershey Cancer Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Western Penn Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Pennsylvania/Thomas Jefferson
Pittsburgh, Pennsylvania, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Avera Transplant Institute
Sioux Falls, South Dakota, United States
Methodist Healthcare Blood and Marrow Transplant Center
Memphis, Tennessee, United States
St. Jude Childrens Research Hospital
Memphis, Tennessee, United States
Sarah Cannon BMT Program
Nashville, Tennessee, United States
VA Tennessee Valley Healthcare System
Nashville, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Amarillo Blood and Marrow Transplant Program
Amarillo, Texas, United States
Medical City Dallas
Dallas, Texas, United States
Children's Medical Center Dallas
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)
Fort Sam Houston, Texas, United States
Cook Children's Hospital
Fort Worth, Texas, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Texas Children's Hospital - Baylor Medical Center
Houston, Texas, United States
Southwest Cancer Treatment & Research Center
Lubbock, Texas, United States
The Children's Hospital of San Antonio
San Antonio, Texas, United States
Methodist Healthcare System of San Antonio/Texas Transplant Institute
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
VA Puget Sound HCS
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
West Virginia University
Morgantown, West Virginia, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Joseph Chewning, MD
Role: primary
Matthew Ulrickson, MD
Role: primary
Roberta Adams, MD
Role: primary
James Slack, MD
Role: primary
Emmanuel Katsanis, MD
Role: primary
Jason Farrar, MD
Role: primary
Monzr Al Malki, MD
Role: primary
Neena Kapoor, MD
Role: primary
James R Mason, MD
Role: primary
Dimitrios Tzachanis, MD
Role: primary
Hisham Abdel-Azim, MD
Role: primary
Gary Schiller, MD
Role: primary
Mark Walters, MD
Role: primary
Rishikesh Chavan, MD
Role: primary
Elias Kiwan, MD
Role: primary
Eric Anderson, MD
Role: primary
Sandhya Kharbanda, MD
Role: primary
Andrew Rezvani, MD
Role: primary
Michael Verneris, MD
Role: primary
Jonathan Gutman, MD
Role: primary
Alireza Eghtedar, MD
Role: primary
Aaron Flagg, MD
Role: primary
Emi Caywood, MD
Role: primary
David Jacobsohn, MD
Role: primary
Jordan Milner, MD
Role: primary
Edward Ziga, MD
Role: primary
Vivek Roy, MD
Role: primary
Edward Ziga, MD, MPH
Role: primary
Jorge Galvez-Silva, MD
Role: primary
Rushang Patel, MD
Role: primary
Susan Kelly, MD
Role: primary
Rikin Shah
Role: primary
Yasser Khaled, MD
Role: primary
Deepakbabu Chellapandian, MD
Role: primary
Ann Haight, MD
Role: primary
Scott Solomon, MD
Role: primary
Vamsi K Kota, MD
Role: primary
Randal Wada, MD
Role: primary
Kehinde Adekola, MD
Role: primary
Sunita Nathan, MD
Role: primary
Damiano Rondelli, MD
Role: primary
Sonali Chaudhury, MD
Role: primary
James LaBelle, MD, PhD
Role: primary
Patrick Hagen, MD
Role: primary
Luke Akard, MD
Role: primary
Jodi Skiles, MD
Role: primary
Margarida Silverman, MD
Role: primary
Joseph McGuirk, DO
Role: primary
Mohamed Hegazi, MD
Role: primary
Hana Safa, MD
Role: primary
Lolie Yu, MD
Role: primary
Allen Chen, MD, PhD
Role: primary
Elizabeth Kang, MD
Role: primary
Richard Childs, MD
Role: primary
Andreas Klein, MD
Role: primary
David Avigan, MD
Role: primary
Corey Cutler, MD
Role: primary
Jan Cerny, MD
Role: primary
Jessica Yu
Role: primary
Sureyya Savasan, MD
Role: primary
Nalini Janakiraman, MD
Role: primary
Troy Quigg, MD
Role: primary
Aly Abdel-Mageed, MD
Role: primary
Carolyn Bigelow, MD
Role: primary
Deepika Bhatla, MD
Role: primary
Sagun Goyal, MD
Role: primary
Geoffrey Uy, MD
Role: primary
Geoffrey Uy, MD
Role: primary
Phyllis Warkenton, MD
Role: primary
Alfred Gillio, MD
Role: primary
Matthew Matasar, MD, MS
Role: primary
Kanwaldeep Mallhi, MD
Role: primary
Ruthee L Bayer, MD
Role: primary
Jonathan Fish, MD
Role: primary
Mohammad M Abdul Hay, MD
Role: primary
Antoine Mesidor
Role: backup
Tsiporah Shore, MD
Role: primary
Alla Keyzner, MD
Role: primary
Monica Bhatia, MD
Role: primary
Ioannis Politikos, MBBS
Role: primary
Mitchell Cairo, MD
Role: primary
Omar Aljitawi, MD
Role: primary
Michael Schuster, MD
Role: primary
Mahvish Rahim, MD
Role: primary
Anson Snow, MD
Role: primary
Jeffrey Huo, MD
Role: primary
Michelle Hyland
Role: backup
Joanne Kurtzberg, MD
Role: primary
Megan Sampson, MD
Role: primary
Stella Davies, MD
Role: primary
Hillard Lazarus, MD
Role: primary
Claudio Brunstein, MD
Role: primary
Rolla Abu-Arja, MD
Role: primary
Sumithira Vasu, MD
Role: primary
Adam Asch, MD
Role: primary
Eneida Nemecek, MD
Role: primary
Shin Mineishi, MD
Role: primary
Timothy Olson, MD
Role: primary
Paul Szabolcs, MD
Role: primary
John Lister, MD
Role: primary
Alison Sehgal, MD
Role: primary
Elizabeth Hexner, MD
Role: primary
Todd Roberts, MD
Role: primary
Michelle Hudspeth, MD
Role: primary
Waqas Jehangir, MD, FACP
Role: primary
Renee Madden, MD
Role: primary
Michael Byrne, MD
Role: primary
Vikas Bhushan, MD
Role: primary
Victor Aquino, MD
Role: primary
Bradley Beeler, MD
Role: primary
Gretchen Eames, MD
Role: primary
Elizabeth Shpall, MD
Role: primary
George Carrum, MD
Role: primary
Martin Andreansky, MD, PhD
Role: primary
Mark Schambura
Role: backup
Jose Cruz, MD
Role: primary
Ahmad Rayes, MD
Role: primary
Karen Ballen, MD
Role: primary
John McCarty, MD
Role: primary
Ann Dahlberg, MD
Role: primary
Lauren Veltri, MD
Role: primary
Kenneth DeSantes, MD
Role: primary
David Margolis, MD
Role: primary
Hamadani Mehdi, MD
Role: primary
Other Identifiers
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NCT01553461
Identifier Type: -
Identifier Source: nct_alias
10-CBA
Identifier Type: -
Identifier Source: org_study_id