← Back to searchRecruitingRecruiting
A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
NCT01351545 · Center for International Blood and Marrow Transplant Research
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official 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
About this study
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 criteria
Inclusion Criteria:
* Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment
* Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment
* Pediatric and adult patients of any age
Exclusion Criteria:
* Patients who are receiving only licensed CBUs
* 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
Study design
Enrollment target: 99999 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2011-10
Estimated completion: 2041-10
Last updated: 2026-04-13
Interventions
Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Primary outcomes
- • Neutrophil recovery of ≥500/mm3 after cord blood transplantation (Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.)
- • Neutrophil recovery of ≥500/mm3 after cord blood transplantation (Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.)
Sponsor
Center for International Blood and Marrow Transplant Research · network
With: National Marrow Donor Program
Contacts & investigators
ContactElizabeth Fosberg, B.A. · contact · 10-CBA@ndmp.org
InvestigatorHeather Stefanski, MD, PhD · study_chair, NMDP/CIBMTR
All locations (142)
University of Alabama at BirminghamRecruiting
Birmingham, Alabama, United States
Banner MD Anderson Cancer CenterRecruiting
Gilbert, Arizona, United States
Phoenix Children's HospitalRecruiting
Phoenix, Arizona, United States
Mayo Clinic Arizona (adults)Recruiting
Phoenix, Arizona, United States
University of Arizona Medical Center - TucsonRecruiting
Tucson, Arizona, United States
Arkansas Children's HospitalRecruiting
Little Rock, Arkansas, United States
City of HopeRecruiting
Duarte, California, United States
Children's Hospital of Los AngelesRecruiting
Glendale, California, United States
Scripps Green HospitalRecruiting
La Jolla, California, United States
University of California San DiegoRecruiting
La Jolla, California, United States
Loma Linda University Cancer CenterRecruiting
Loma Linda, California, United States
UCLARecruiting
Los Angeles, California, United States
Children's Hospital and Research Center of OaklandCompleted
Oakland, California, United States
Children's Hospital of Orange County (CHOC)Recruiting
Orange, California, United States
Sutter Medical CenterRecruiting
Sacramento, California, United States
Rady Children's Hospital San DiegoRecruiting
San Diego, California, United States
UCSF (adults)Suspended
San Francisco, California, United States
UCSF (Peds)Recruiting
San Francisco, California, United States
Stanford University Medical CenterRecruiting
Stanford, California, United States
Children's Hospital ColoradoRecruiting
Aurora, Colorado, United States
University of Colorado HospitalRecruiting
Aurora, Colorado, United States
Presbyterian St. Luke's/Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
Yale New Haven HospitalRecruiting
New Haven, Connecticut, United States
Nemours - Alfred I. duPont Hospital for ChildrenRecruiting
Brandywine, Delaware, United States
Children's National Medical CenterRecruiting
Washington D.C., District of Columbia, United States
University of Florida Shands Medical CenterRecruiting
Gainesville, Florida, United States
Nemours Children's Hospital - Mayo JacksonvilleRecruiting
Jacksonville, Florida, United States
Mayo Clinic - JacksonvilleWithdrawn
Jacksonville, Florida, United States
University of Miami (adult)Completed
Miami, Florida, United States
University of Miami (peds)Recruiting
Miami, Florida, United States
Niklaus Children's HospitalRecruiting
Miami, Florida, United States
AdventHealth OrlandoRecruiting
Orlando, Florida, United States
Florida Center for Pediatric Cellular TherapyRecruiting
Orlando, Florida, United States
Orlando Health Arnold Palmer Hospital for ChildrenRecruiting
Orlando, Florida, United States
Orlando Health Cancer Institute Bone Marrow Transplant and Cellular TherapyRecruiting
Orlando, Florida, United States
All Children's HospitalRecruiting
St. Petersburg, Florida, United States
H Lee Moffitt Cancer CenterTerminated
Tampa, Florida, United States
Children's Healthcare of AtlantaRecruiting
Atlanta, Georgia, United States
Emory University HospitalTerminated
Atlanta, Georgia, United States
Northside HospitalRecruiting
Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University HealthRecruiting
Augusta, Georgia, United States
Kapiolani Medical Center for Women and ChildrenRecruiting
Honolulu, Hawaii, United States
Northwestern Memorial HospitalRecruiting
Chicago, Illinois, United States
Rush University Medical CenterRecruiting
Chicago, Illinois, United States
University of Illinois at ChicagoRecruiting
Chicago, Illinois, United States
Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
Chicago, Illinois, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Loyola University Medical CenterRecruiting
Maywood, Illinois, United States
Advocate Lutheran General HospitalTerminated
Park Ridge, Illinois, United States
Midwestern Regional Medical CenterTerminated
Zion, Illinois, United States
Indiana Blood & Marrow TransplantationCompleted
Beech Grove, Indiana, United States
Indiana University/Riley Hospital for ChildrenRecruiting
Indianapolis, Indiana, United States
University of IowaRecruiting
Iowa City, Iowa, United States
University of KansasRecruiting
Westwood, Kansas, United States
University of Louisville Hospital - James Brown Cancer CenterRecruiting
Louisville, Kentucky, United States
Tulane Medical CenterRecruiting
New Orleans, Louisiana, United States
Children's Hospital of New Orleans/LSUHSCRecruiting
New Orleans, Louisiana, United States
Greenebaum Cancer Center - University of MarylandWithdrawn
Baltimore, Maryland, United States
Johns HopkinsRecruiting
Baltimore, Maryland, United States
Nih/NiaidRecruiting
Bethesda, Maryland, United States
NIH/NCITerminated
Bethesda, Maryland, United States
Nih/NhlbiRecruiting
Bethesda, Maryland, United States
Tufts Medical CenterRecruiting
Boston, Massachusetts, United States
Massachusetts General HospitalSuspended
Boston, Massachusetts, United States
Beth Israel DeaconessRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
University of MassachusettsRecruiting
Worcester, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Children's Hospital of MichiganRecruiting
Detroit, Michigan, United States
Karmanos Cancer InstituteSuspended
Detroit, Michigan, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Helen DeVos Children's HospitalRecruiting
Grand Rapids, Michigan, United States
Spectrum HealthRecruiting
Grand Rapids, Michigan, United States
Mayo Clinic RochesterTerminated
Rochester, Minnesota, United States
Univeristy of Mississippi Medical CenterRecruiting
Jackson, Mississippi, United States
Children's Mercy Hospital and ClinicsSuspended
Kansas City, Missouri, United States
Cardinal Glennon Children's Medical CenterRecruiting
St Louis, Missouri, United States
St. Louis University Medical CenterRecruiting
St Louis, Missouri, United States
Washington University St. LouisRecruiting
St Louis, Missouri, United States
Washington University/St. Louis Children's HospitalRecruiting
St Louis, Missouri, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Robert Wood Johnson/Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
North Shore University HospitalRecruiting
Lake Sucess, New York, United States
Cohen Children's Medical Center of New YorkRecruiting
New Hyde, New York, United States
New York University Langone Medical CenterRecruiting
New York, New York, United States
New York Presbyterian Hospital at CornellRecruiting
New York, New York, United States
Mount Sinai Medical Center - New YorkRecruiting
New York, New York, United States
Columbia University Medical Center - Morgan Stanley Children's HospitalRecruiting
New York, New York, United States
Memorial Sloan-Kettering Cancer CenterRecruiting
New York, New York, United States
Westchester Medical CenterRecruiting
New York, New York, United States
Strong Memorial Hospital/University of RochesterRecruiting
Rochester, New York, United States
Stony Brook University HospitalRecruiting
Stony Brook, New York, United States
Children's Hospital at MontefioreRecruiting
The Bronx, New York, United States
University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Levine Children's HospitalRecruiting
Charlotte, North Carolina, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Wake Forest UniversityWithdrawn
Winston-Salem, North Carolina, United States
Childrens Hospital Medical Center of AkronRecruiting
Akron, Ohio, United States
Cincinnati Children's HospitalRecruiting
Cincinnati, Ohio, United States
The Jewish HospitalWithdrawn
Cincinnati, Ohio, United States
University Hospitals Case Medical CenterRecruiting
Cleveland, Ohio, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Nationwide Children's HospitalRecruiting
Columbus, Ohio, United States
The Arthur G. James Cancer Hospital/The Ohio State University Medical CenterRecruiting
Columbus, Ohio, United States
University of Oklahoma Health Science CenterRecruiting
Oklahoma City, Oklahoma, United States
Oregon Health & Science University/Doernbecher Children's HospitalRecruiting
Portland, Oregon, United States
Penn State Milton S. Hershey Cancer CenterRecruiting
Hershey, Pennsylvania, United States
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
Children's Hospital of PittsburghRecruiting
Pittsburgh, Pennsylvania, United States
West Penn HospitalRecruiting
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
University of Pennsylvania/Thomas JeffersonRecruiting
Pittsburgh, Pennsylvania, United States
Roger Williams Medical CenterRecruiting
Providence, Rhode Island, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
Avera Transplant InstituteRecruiting
Sioux Falls, South Dakota, United States
Methodist Healthcare Blood and Marrow Transplant CenterCompleted
Memphis, Tennessee, United States
St. Jude Childrens Research HospitalRecruiting
Memphis, Tennessee, United States
Sarah Cannon BMT ProgramSuspended
Nashville, Tennessee, United States
VA Tennessee Valley Healthcare SystemWithdrawn
Nashville, Tennessee, United States
Vanderbilt UniversityRecruiting
Nashville, Tennessee, United States
Amarillo Blood and Marrow Transplant ProgramTerminated
Amarillo, Texas, United States
Medical City DallasRecruiting
Dallas, Texas, United States
Children's Medical Center DallasRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical CenterWithdrawn
Dallas, Texas, United States
Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)Recruiting
Fort Sam Houston, Texas, United States
Cook Children's HospitalRecruiting
Fort Worth, Texas, United States
M.D. Anderson Cancer CenterRecruiting
Houston, Texas, United States
Texas Children's Hospital - Baylor Medical CenterRecruiting
Houston, Texas, United States
Southwest Cancer Treatment & Research CenterWithdrawn
Lubbock, Texas, United States
The Children's Hospital of San AntonioRecruiting
San Antonio, Texas, United States
Methodist Healthcare System of San Antonio/Texas Transplant InstituteRecruiting
San Antonio, Texas, United States
University of UtahRecruiting
Salt Lake City, Utah, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Virginia Commonwealth UniversityRecruiting
Richmond, Virginia, United States
VA Puget Sound HCSSuspended
Seattle, Washington, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
West Virginia UniversityRecruiting
Morgantown, West Virginia, United States
University of Wisconsin - MadisonRecruiting
Madison, Wisconsin, United States
Children's Hospital of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Medical College of WisconsinCompleted
Milwaukee, Wisconsin, United States