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.
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational |
| Eligible Ages | N/A and Over |
| Gender | All |
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT01351545 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Center for International Blood and Marrow Transplant Research |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
John Miller, MD, PhD |
| Principal Investigator Affiliation | NMDP/CIBMTR |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia |
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:
: Unlicensed CBU
The cohort includes recipients of any age receiving unlicensed cryopreserved cord blood units (CBUs) for designated indications.
Drug: - 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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Status
Recruiting
Address
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Status
Recruiting
Address
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Status
Recruiting
Address
Mayo Clinic Arizona (adults)
Phoenix, Arizona, 85054
Status
Recruiting
Address
University of Arizona Medical Center - Tucson
Tucson, Arizona, 85224
Status
Recruiting
Address
City of Hope
Duarte, California, 91010
Status
Recruiting
Address
Children's Hospital of Los Angeles
Glendale, California, 91204
Status
Recruiting
Address
Scripps Green Hospital
La Jolla, California, 92037
Status
Recruiting
Address
University of California San Diego
La Jolla, California, 92093
Status
Recruiting
Address
Loma Linda University Cancer Center
Loma Linda, California, 92350
Status
Recruiting
Address
UCLA
Los Angeles, California, 90095
Status
Recruiting
Address
Children's Hospital and Research Center of Oakland
Oakland, California, 94609
Status
Recruiting
Address
Children's Hospital of Orange County (CHOC)
Orange, California, 92868
Status
Recruiting
Address
Sutter Medical Center
Sacramento, California, 95816
Status
Recruiting
Address
Rady Children's Hospital San Diego
San Diego, California, 92123
Status
Recruiting
Address
UCSF (adults)
San Francisco, California, 94143
Status
Recruiting
Address
UCSF (peds)
San Francisco, California, 94143
Status
Recruiting
Address
Stanford University Medical Center
Stanford, California, 94304
Status
Recruiting
Address
Children's Hospital Colorado
Aurora, Colorado, 80045
Status
Recruiting
Address
University of Colorado Hospital
Aurora, Colorado, 80045
Status
Recruiting
Address
Presbyterian St. Luke's/Colorado Blood Cancer Institute
Denver, Colorado, 80218
Status
Recruiting
Address
Yale New Haven Hospital
New Haven, Connecticut, 06510
Status
Recruiting
Address
Nemours - Alfred I. duPont Hospital for Children
Brandywine, Delaware, 19803
Status
Recruiting
Address
Children's National Medical Center
Washington, District of Columbia, 20010
Status
Recruiting
Address
University of Florida Shands Medical Center
Gainesville, Florida, 32610
Status
Recruiting
Address
Nemours Children's Hospital - Mayo Jacksonville
Jacksonville, Florida, 32207
Status
Recruiting
Address
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
Status
Recruiting
Address
University of Miami (adult)
Miami, Florida, 33136
Status
Recruiting
Address
University of Miami (peds)
Miami, Florida, 33136
Status
Recruiting
Address
Niklaus Children's Hospital
Miami, Florida, 33155
Status
Recruiting
Address
AdventHealth Orlando
Orlando, Florida, 32804
Status
Recruiting
Address
Florida Center for Pediatric Cellular Therapy
Orlando, Florida, 32804
Status
Not yet recruiting
Address
Orlando Health Bone Marrow Transplant and Cellular Therapy
Orlando, Florida, 32806
Status
Recruiting
Address
All Children's Hospital
Saint Petersburg, Florida, 33701
Status
Terminated
Address
H Lee Moffitt Cancer Center
Tampa, Florida, 33612
Site Contact
Status
Recruiting
Address
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Status
Terminated
Address
Emory University Hospital
Atlanta, Georgia, 30322
Site Contact
Status
Recruiting
Address
Northside Hospital
Atlanta, Georgia, 30342
Status
Recruiting
Address
Medical College of Georgia
Augusta, Georgia, 30912
Status
Recruiting
Address
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96813
Status
Recruiting
Address
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Status
Recruiting
Address
Rush University Medical Center
Chicago, Illinois, 60612
Status
Recruiting
Address
University of Illinois at Chicago
Chicago, Illinois, 60612
Status
Recruiting
Address
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614
Status
Recruiting
Address
University of Chicago
Chicago, Illinois, 60637
Status
Recruiting
Address
Loyola University Medical Center
Maywood, Illinois, 60153
Status
Terminated
Address
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Site Contact
Status
Terminated
Address
Midwestern Regional Medical Center
Zion, Illinois, 60099
Site Contact
Status
Recruiting
Address
Indiana Blood & Marrow Transplantation
Beech Grove, Indiana, 46107
Status
Recruiting
Address
Indiana University/Riley Hospital for Children
Indianapolis, Indiana, 46202
Status
Recruiting
Address
University of Iowa
Iowa City, Iowa, 52242
Status
Recruiting
Address
University of Kansas
Westwood, Kansas, 66205
Status
Recruiting
Address
University of Louisville Hospital - James Brown Cancer Center
Louisville, Kentucky, 40202
Status
Recruiting
Address
Tulane Medical Center
New Orleans, Louisiana, 70112
Status
Recruiting
Address
Children's Hospital of New Orleans/LSUHSC
New Orleans, Louisiana, 70118
Status
Withdrawn
Address
Greenebaum Cancer Center - University of Maryland
Baltimore, Maryland, 21201
Site Contact
Status
Recruiting
Address
Johns Hopkins
Baltimore, Maryland, 21287
Status
Recruiting
Address
Nih/Niaid
Bethesda, Maryland, 20892-1456
Status
Recruiting
Address
Nih/Nhlbi
Bethesda, Maryland, 20892
Status
Recruiting
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Suspended
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Site Contact
Status
Suspended
Address
Beth Israel Deaconess
Boston, Massachusetts, 02215
Site Contact
Status
Recruiting
Address
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Status
Recruiting
Address
University of Massachusetts
Worcester, Massachusetts, 01655
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Children's Hospital of Michigan
Detroit, Michigan, 48201
Status
Suspended
Address
Karmanos Cancer Institute
Detroit, Michigan, 48201
Site Contact
Status
Recruiting
Address
Henry Ford Health System
Detroit, Michigan, 48202
Status
Recruiting
Address
Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
Status
Recruiting
Address
Spectrum Health
Grand Rapids, Michigan, 49503
Status
Recruiting
Address
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Status
Recruiting
Address
Univeristy of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Suspended
Address
Children's Mercy Hospital and Clinics
Kansas City, Missouri, 64108
Site Contact
Status
Recruiting
Address
Cardinal Glennon Children's Medical Center
Saint Louis, Missouri, 63104
Status
Recruiting
Address
St. Louis University Medical Center
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Washington University St. Louis
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Washington University/St. Louis Children's Hospital
Saint Louis, Missouri, 63110
Status
Recruiting
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2168
Status
Recruiting
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Recruiting
Address
Robert Wood Johnson/Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Status
Recruiting
Address
Children's Hospital at Montefiore
Bronx, New York, 10467
Status
Recruiting
Address
Roswell Park Cancer Institute
Buffalo, New York, 14263
Status
Recruiting
Address
North Shore University Hospital
Lake Success, New York, 11042
Status
Recruiting
Address
Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040
Status
Recruiting
Address
New York University Langone Medical Center
New York, New York, 10016
Status
Recruiting
Address
New York Presbyterian Hospital at Cornell
New York, New York, 10021
Status
Recruiting
Address
Mount Sinai Medical Center
New York, New York, 10029
Status
Recruiting
Address
Columbia University Medical Center - Morgan Stanley Children's Hospital
New York, New York, 10032
Status
Recruiting
Address
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Status
Recruiting
Address
Westchester Medical Center
New York, New York, 10595
Status
Recruiting
Address
Strong Memorial Hospital/University of Rochester
Rochester, New York, 14642-8704
Status
Recruiting
Address
Stony Brook University Hospital
Stony Brook, New York, 11794
Status
Recruiting
Address
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Status
Recruiting
Address
Levine Children's Hospital
Charlotte, North Carolina, 28203
Status
Recruiting
Address
Duke University Medical Center
Durham, North Carolina, 27705
Status
Withdrawn
Address
Wake Forest University
Winston-Salem, North Carolina, 27157
Site Contact
Status
Recruiting
Address
Childrens Hospital Medical Center of Akron
Akron, Ohio, 44308
Status
Recruiting
Address
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Status
Recruiting
Address
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Status
Recruiting
Address
Cleveland Clinic
Cleveland, Ohio, 44195
Status
Recruiting
Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
Status
Recruiting
Address
The Arthur G. James Cancer Hospital/The Ohio State University Medical Center
Columbus, Ohio, 43210
Status
Recruiting
Address
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73103
Status
Recruiting
Address
Oregon Health & Science University/Doernbecher Children's Hospital
Portland, Oregon, 97239
Status
Recruiting
Address
Penn State Milton S. Hershey Cancer Center
Hershey, Pennsylvania, 17033
Status
Recruiting
Address
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
Western Penn Hospital
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Status
Recruiting
Address
University of Pennsylvania/Thomas Jefferson
Pittsburgh, Pennsylvania, 19104
Status
Recruiting
Address
Roger Williams Medical Center
Providence, Rhode Island, 02908
Status
Recruiting
Address
Medical University of South Carolina
Charleston, South Carolina, 29425
Status
Recruiting
Address
Avera Transplant Institute
Sioux Falls, South Dakota, 57105
Status
Recruiting
Address
Methodist Healthcare Blood and Marrow Transplant Center
Memphis, Tennessee, 38104
Status
Recruiting
Address
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
Status
Recruiting
Address
Sarah Cannon BMT Program
Nashville, Tennessee, 37203
Status
Withdrawn
Address
VA Tennessee Valley Healthcare System
Nashville, Tennessee, 37212
Site Contact
Status
Recruiting
Address
Vanderbilt University
Nashville, Tennessee, 37232
Status
Terminated
Address
Amarillo Blood and Marrow Transplant Program
Amarillo, Texas, 79106
Site Contact
Status
Recruiting
Address
Medical City Dallas
Dallas, Texas, 75230
Status
Recruiting
Address
Children's Medical Center Dallas
Dallas, Texas, 75235
Status
Withdrawn
Address
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Site Contact
Status
Recruiting
Address
Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)
Fort Sam Houston, Texas, 78234
Status
Recruiting
Address
Cook Children's Hospital
Fort Worth, Texas, 76104
Status
Recruiting
Address
M.D. Anderson Cancer Center
Houston, Texas, 77030
Status
Recruiting
Address
Texas Children's Hospital - Baylor Medical Center
Houston, Texas, 77030
Status
Withdrawn
Address
Southwest Cancer Treatment & Research Center
Lubbock, Texas, 79415
Site Contact
Status
Recruiting
Address
The Children's Hospital of San Antonio
San Antonio, Texas, 78207
Status
Recruiting
Address
Methodist Healthcare System of San Antonio/Texas Transplant Institute
San Antonio, Texas, 78229
Status
Recruiting
Address
University of Utah
Salt Lake City, Utah, 84132
Status
Recruiting
Address
University of Virginia
Charlottesville, Virginia, 22908
Status
Recruiting
Address
Virginia Commonwealth University
Richmond, Virginia, 23227
Status
Recruiting
Address
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
Status
Recruiting
Address
West Virginia University
Morgantown, West Virginia, 26506-8110
Status
Recruiting
Address
University of Wisconsin - Madison
Madison, Wisconsin, 53792
Status
Recruiting
Address
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Status
Recruiting
Address
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
