A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
- Conditions
- Hematologic MalignanciesInherited Disorders of MetabolismInherited Abnormalities of PlateletsHistiocytic DisordersAcute Myelogenous Leukemia (AML or ANLL)Acute Lymphoblastic Leukemia (ALL)Other Acute LeukemiaChronic Myelogenous Leukemia (CML)Myelodysplastic (MDS) / Myeloproliferative (MPN) DiseasesOther Leukemia
- Interventions
- Drug: A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
- Registration Number
- NCT01351545
- Brief 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 99999
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Unlicensed CBU A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
- Primary Outcome Measures
Name Time Method 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. The primary objective of this access and distribution protocol 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 FDA licensed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (141)
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
University of California San Diego
🇺🇸La Jolla, California, United States
Scripps Green Hospital
🇺🇸LaJolla, 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 DC, 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 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
Medical College of Georgia
🇺🇸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
Children's Hospital at Montefiore
🇺🇸Bronx, New York, 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, 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
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
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Western Penn Hospital
🇺🇸Pittsburg, Pennsylvania, United States
University of Pennsylvania/Thomas Jefferson
🇺🇸Pittsburg, 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