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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


N/A
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N/A
Open (Enrolling)
Both
Hematological Malignancies, Certain Lysosomal Storage and Peroxisomal Enzyme Deficiency Disorders, Hurler Syndrome (MPS I), Krabbe Disease (Globoid Leukodystrophy), X-linked Adrenoleukodystrophy, Primary Immunodeficiency Diseases, Bone Marrow Failure, Beta-thalassemia

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Trial Information

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


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


Inclusion Criteria:



- Patients with FDA-specified indications: Hematological malignancies, Certain
lysosomal storage and peroxisomal enzyme deficiency disorders (Hurler syndrome (MPS
I), Krabbe Disease (Globoid Leukodystrophy),and X-linked Adrenoleukodystrophy),
Primary immunodeficiency diseases, Bone marrow failure, and Beta-thalassemia

- Signed informed consent (and signed assent, if applicable)

- Pediatric and adult patients of any age

Exclusion Criteria:

- Patients who are receiving only licensed CBUs

- Cord blood transplant recipients at international transplant centers

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Authority:

United States: Food and Drug Administration

Study ID:

10-CBA

NCT ID:

NCT01351545

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Hematological Malignancies
  • Certain Lysosomal Storage and Peroxisomal Enzyme Deficiency Disorders
  • Hurler Syndrome (MPS I)
  • Krabbe Disease (Globoid Leukodystrophy)
  • X-linked Adrenoleukodystrophy
  • Primary Immunodeficiency Diseases
  • Bone Marrow Failure
  • Beta-Thalassemia
  • Beta-Thalassemia
  • Neoplasms
  • Leukodystrophy, Globoid Cell
  • Immunologic Deficiency Syndromes
  • Pancytopenia
  • Thalassemia
  • Mucopolysaccharidosis I
  • Adrenoleukodystrophy
  • Hematologic Neoplasms

Name

Location

Wake Forest UniversityWinston-Salem, North Carolina  27103
University of IowaIowa City, Iowa  52242
University of MichiganAnn Arbor, Michigan  48109-0624
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Stanford University Medical CenterStanford, California  94305-5408
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Children's Hospital of MichiganDetroit, Michigan  48201
Loyola University Medical CenterMaywood, Illinois  60153
Medical College of WisconsinMilwaukee, Wisconsin  53226
Northwestern Memorial HospitalChicago, Illinois  60611
New York Medical CollegeValhalla, New York  10595
Rush University Medical CenterChicago, Illinois  60612-3824
Cedars-Sinai Medical CenterLos Angeles, California  90048
Midwestern Regional Medical CenterZion, Illinois  60099
North Shore University HospitalManhasset, New York  11030
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Miami Children's HospitalMiami, Florida  33155-4069
Florida Hospital Cancer InstituteOrlando, Florida  32804
All Children's HospitalSt. Petersburg, Florida  33701
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
University of Illinois at ChicagoChicago, Illinois  60612
Roger Williams Medical CenterProvidence, Rhode Island  02908-4735
Mount Sinai Medical CenterNew York, New York  10029
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Baylor University Medical CenterDallas, Texas  75246
University of California San DiegoLa Jolla, California  92093
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Seattle Cancer Care AllianceSeattle, Washington  98109
City of HopeDuarte, California  91010
University of VirginiaCharlottesville, Virginia  22908
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of UtahSalt Lake City, Utah  
Vanderbilt UniversityNashville, Tennessee  37232-6305
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Children's Hospital of WisconsinMilwaukee, Wisconsin  53201
Henry Ford Health SystemDetroit, Michigan  48202
Cleveland ClinicCleveland, Ohio  44195
Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of Colorado HospitalDenver, Colorado  80262
M.D. Anderson Cancer CenterHouston, Texas  77030
H Lee Moffitt Cancer CenterTampa, Florida  33612
University of ChicagoChicago, Illinois  60637
University of Texas Southwestern Medical CenterDallas, Texas  
UCLALos Angeles, California  90095
University of KentuckyLexington, Kentucky  40536-0098
Stony Brook University HospitalStony Brook, New York  11794-8174
Texas Transplant InstituteSan Antonio, Texas  78229
Children's Memorial HospitalChicago, Illinois  60614
UC Davis Cancer CenterSacramento, California  95817
Tufts Medical CenterBoston, Massachusetts  02111
Virginia Commonwealth UniversityRichmond, Virginia  
St. Louis UniversitySt. Louis, Missouri  63110
Karmanos Cancer InstituteDetroit, Michigan  48201
Scripps Green HospitalLa Jolla, California  92037
Children's Healthcare of AtlantaAtlanta, Georgia  30342
University of MassachusettsWorcester, Massachusetts  01655
Northside HospitalAtlanta, Georgia  30342
West Virginia UniversityMorgantown, West Virginia  26506
Johns HopkinsBaltimore, Maryland  21231
Mayo Clinic RochesterRochester, Minnesota  55905
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Emory University HospitalAtlanta, Georgia  30322
University of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
Cincinnati Children's HospitalCincinnati, Ohio  45229
Duke University Medical Center (Peds)Durham, North Carolina  27705
University Hospitals Case Medical CenterCleveland, Ohio  44106
Children's Hospital of Los AngelesLos Angeles, California  90027
Rady Children's Hospital San DiegoSan Diego, California  92123
Yale New Haven HospitalNew Haven, Connecticut  06520
The Jewish HospitalCincinnati, Ohio  45236
Children's Mercy Hospital and ClinicsKansas City, Missouri  64108
Beth Israel DeaconessBoston, Massachusetts  02215
Sutter Medical CenterSacramento, California  95816
Helen DeVos Children's HospitalGrand Rapids, Michigan  49503
Cardinal Glennon Children's Medical CenterSt. Louis, Missouri  63104
Cook Children's HospitalFort Worth, Texas  76104
Children's Medical Center DallasDallas, Texas  75235
University Of KansasKansas City, Kansas  66160
Greenebaum Cancer Center - University of MarylandBaltimore, Maryland  21201
University of Wisconsin - MadisonMadison, Wisconsin  53792
Florida Center for Cellular TherapyOrlando, Florida  32804
VA Puget Sound HCSSeattle, Washington  98108
Children's Hospital of Orange County (CHOC)Orange, California  92868
Children's Hospital ColoradoAurora, Colorado  80045
Washington University St. LouisSt. Louis, Missouri  63110
St. Jude Childrens Research HospitalMemphis, Tennessee  38105
Mayo Clinic Arizona (adults)Phoenix, Arizona  85054
University of Arizona Medical Center - TucsonTucson, Arizona  85224
Loma Linda Universoty Cancer CenterLoma Linda, California  92350
Children's Hospital and Research Center of OaklandOakland, California  94609
UCSF (adults)San Francisco, California  94143
UCSF (peds)San Francisco, California  94143
Presbyterian St. Luke's/Colorado Blood Cancer InstituteDenver, Colorado  80218
Nemours - Alfred I. duPont Hospital for ChildrenBrandywine, Delaware  19803
University of Florida Shands Medical CenterGainesville, Florida  32610
Nemours Children's Hospital - Mayo JacksonvilleJacksonville, Florida  32207
Mayo Clinic - Jacksonville (adults)Jacksonville, Florida  32224
University of Miami (adult)Miami, Florida  33136
University of Miami (peds)Miami, Florida  
Indiana Blood & Marrow TransplantationBeech Grove, Illinois  46107
Indiana University Bone Marrow and SCT ProgramIndianapolis, Indiana  46202
University of Louisville Hospital - James Brown Cancer CenterLouisville, Kentucky  40202
Tulane Medical CenterNew Orleans, Louisiana  70112
Children's Hospital of New Orleans/LSUHSCNew Orleans, Louisiana  70118
Nih/NiaidBethesda, Maryland  20892-1456
NIH/NCIBethesda, Maryland  20892
Nih/NhlbiBethesda, Maryland  20892
Univeristy of Mississippi Medical CenterJackson, Michigan  39216
St. Louis Children'sSt. Louis, Missouri  63110
Robert Wood Johnson/Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Cohen Children's Medical Center of New YorkNew Hyde, New York  11040
New York Presbyterian Hospital at CornellNew York, New York  10021
Columbia University Medical Center - Morgan Stanley Children's HospitalNew York, New York  10032
Strong Memorial Hospital/University of RochesterRochester, New York  14642-8704
Duke Universoty Medical Center (adults)Durham, North Carolina  27705
Childrens Hospital Medical Center of AkronAkron, Ohio  44308
The Arthur G. James Cancer Hospital/The Ohio State University Medical CenterColumbus, Ohio  43210
Oregon Health & Science University/Doernbecher Children's HospitalPortland, Oregon  97239
Penn State Milton S. Hershey Cancer CenterHershey, Pennsylvania  17033
University of Pennsylvania/Thomas JeffersonPittsburg, Pennsylvania  19104
West Penn HospitalPittsburg, Pennsylvania  15224
Avera Transplant InstituteSioux Falls, South Dakota  57105
Vanderbilt Veterans HospitalNashville, Tennessee  37212
Amarillo Blood and Marrow Transplant ProgramAmarillo, Texas  79106
Medical City DallasDallas, Texas  75230
Zachary and Elizabeth M Fisher Bome Marrow Transplant UnitFork Sam Houston, Texas  78234-6200
Texas Children's Hospital - Baylor Medical CenterHouston, Texas  77030
Southwest Cancer Treatment & Research CenterLubbock, Texas  79415
Intermountain Blood and Marrow Transplant ProgramSalt Lake City, Utah  84143
Scottsdale Healthcare/Cancer Transplant Institute at Virginia G. Piper Cancer CenterScottsdale, Arizona  85260
Levine Children's Hospital/Carolinas Medical CenterCharlotte, North Carolina