A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Sponsor
Center for International Blood and Marrow Transplant Research (Other)
Overall Status
Recruiting
CT.gov ID
NCT01351545
Collaborator
National Marrow Donor Program (Other)
99,999
139
360
719.4
2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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
Study Design
Study Type:
Observational
Anticipated Enrollment
:
99999 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Study Start Date
:
Oct 1, 2011
Anticipated Primary Completion Date
:
Oct 1, 2041
Anticipated Study Completion Date
:
Oct 1, 2041
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- 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.]
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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
| 3 | Phoenix Children's Hospital | Phoenix | Arizona | United States | 85016 |
| 4 | Mayo Clinic Arizona (adults) | Phoenix | Arizona | United States | 85054 |
| 5 | University of Arizona Medical Center - Tucson | Tucson | Arizona | United States | 85224 |
| 6 | City of Hope | Duarte | California | United States | 91010 |
| 7 | Children's Hospital of Los Angeles | Glendale | California | United States | 91204 |
| 8 | Scripps Green Hospital | La Jolla | California | United States | 92037 |
| 9 | University of California San Diego | La Jolla | California | United States | 92093 |
| 10 | Loma Linda University Cancer Center | Loma Linda | California | United States | 92350 |
| 11 | UCLA | Los Angeles | California | United States | 90095 |
| 12 | Children's Hospital and Research Center of Oakland | Oakland | California | United States | 94609 |
| 13 | Children's Hospital of Orange County (CHOC) | Orange | California | United States | 92868 |
| 14 | Sutter Medical Center | Sacramento | California | United States | 95816 |
| 15 | Rady Children's Hospital San Diego | San Diego | California | United States | 92123 |
| 16 | UCSF (adults) | San Francisco | California | United States | 94143 |
| 17 | UCSF (peds) | San Francisco | California | United States | 94143 |
| 18 | Stanford University Medical Center | Stanford | California | United States | 94304 |
| 19 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
| 20 | University of Colorado Hospital | Aurora | Colorado | United States | 80045 |
| 21 | Presbyterian St. Luke's/Colorado Blood Cancer Institute | Denver | Colorado | United States | 80218 |
| 22 | Yale New Haven Hospital | New Haven | Connecticut | United States | 06510 |
| 23 | Nemours - Alfred I. duPont Hospital for Children | Brandywine | Delaware | United States | 19803 |
| 24 | Children's National Medical Center | Washington | District of Columbia | United States | 20010 |
| 25 | University of Florida Shands Medical Center | Gainesville | Florida | United States | 32610 |
| 26 | Nemours Children's Hospital - Mayo Jacksonville | Jacksonville | Florida | United States | 32207 |
| 27 | Mayo Clinic - Jacksonville | Jacksonville | Florida | United States | 32224 |
| 28 | University of Miami (adult) | Miami | Florida | United States | 33136 |
| 29 | University of Miami (peds) | Miami | Florida | United States | 33136 |
| 30 | Niklaus Children's Hospital | Miami | Florida | United States | 33155 |
| 31 | AdventHealth Orlando | Orlando | Florida | United States | 32804 |
| 32 | Florida Center for Pediatric Cellular Therapy | Orlando | Florida | United States | 32804 |
| 33 | All Children's Hospital | Saint Petersburg | Florida | United States | 33701 |
| 34 | H Lee Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
| 35 | Children's Healthcare of Atlanta | Atlanta | Georgia | United States | 30322 |
| 36 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
| 37 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
| 38 | Medical College of Georgia | Augusta | Georgia | United States | 30912 |
| 39 | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | United States | 96813 |
| 40 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
| 41 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
| 42 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 43 | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | United States | 60614 |
| 44 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 45 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
| 46 | Advocate Lutheran General Hospital | Park Ridge | Illinois | United States | 60068 |
| 47 | Midwestern Regional Medical Center | Zion | Illinois | United States | 60099 |
| 48 | Indiana Blood & Marrow Transplantation | Beech Grove | Indiana | United States | 46107 |
| 49 | Indiana University/Riley Hospital for Children | Indianapolis | Indiana | United States | 46202 |
| 50 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 51 | University of Kansas | Westwood | Kansas | United States | 66205 |
| 52 | University of Louisville Hospital - James Brown Cancer Center | Louisville | Kentucky | United States | 40202 |
| 53 | Tulane Medical Center | New Orleans | Louisiana | United States | 70112 |
| 54 | Children's Hospital of New Orleans/LSUHSC | New Orleans | Louisiana | United States | 70118 |
| 55 | Greenebaum Cancer Center - University of Maryland | Baltimore | Maryland | United States | 21201 |
| 56 | Johns Hopkins | Baltimore | Maryland | United States | 21287 |
| 57 | Nih/Niaid | Bethesda | Maryland | United States | 20892-1456 |
| 58 | NIH/NCI | Bethesda | Maryland | United States | 20892 |
| 59 | Nih/Nhlbi | Bethesda | Maryland | United States | 20892 |
| 60 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 61 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 62 | Beth Israel Deaconess | Boston | Massachusetts | United States | 02215 |
| 63 | Dana Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 64 | University of Massachusetts | Worcester | Massachusetts | United States | 01655 |
| 65 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 66 | Children's Hospital of Michigan | Detroit | Michigan | United States | 48201 |
| 67 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 68 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
| 69 | Helen DeVos Children's Hospital | Grand Rapids | Michigan | United States | 49503 |
| 70 | Spectrum Health | Grand Rapids | Michigan | United States | 49503 |
| 71 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
| 72 | Univeristy of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
| 73 | Children's Mercy Hospital and Clinics | Kansas City | Missouri | United States | 64108 |
| 74 | Cardinal Glennon Children's Medical Center | Saint Louis | Missouri | United States | 63104 |
| 75 | St. Louis University Medical Center | Saint Louis | Missouri | United States | 63110 |
| 76 | Washington University St. Louis | Saint Louis | Missouri | United States | 63110 |
| 77 | Washington University/St. Louis Children's Hospital | Saint Louis | Missouri | United States | 63110 |
| 78 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-2168 |
| 79 | Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
| 80 | Robert Wood Johnson/Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08901 |
| 81 | Children's Hospital at Montefiore | Bronx | New York | United States | 10467 |
| 82 | Roswell Park Cancer Institute | Buffalo | New York | United States | 14263 |
| 83 | North Shore University Hospital | Lake Success | New York | United States | 11042 |
| 84 | Cohen Children's Medical Center of New York | New Hyde Park | New York | United States | 11040 |
| 85 | New York University Langone Medical Center | New York | New York | United States | 10016 |
| 86 | New York Presbyterian Hospital at Cornell | New York | New York | United States | 10021 |
| 87 | Mount Sinai Medical Center | New York | New York | United States | 10029 |
| 88 | Columbia University Medical Center - Morgan Stanley Children's Hospital | New York | New York | United States | 10032 |
| 89 | Memorial Sloan-Kettering Cancer Center | New York | New York | United States | 10065 |
| 90 | Westchester Medical Center | New York | New York | United States | 10595 |
| 91 | Strong Memorial Hospital/University of Rochester | Rochester | New York | United States | 14642-8704 |
| 92 | Stony Brook University Hospital | Stony Brook | New York | United States | 11794 |
| 93 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 94 | Levine Children's Hospital | Charlotte | North Carolina | United States | 28203 |
| 95 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
| 96 | Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
| 97 | Childrens Hospital Medical Center of Akron | Akron | Ohio | United States | 44308 |
| 98 | Cincinnati Children's Hospital | Cincinnati | Ohio | United States | 45229 |
| 99 | The Jewish Hospital | Cincinnati | Ohio | United States | 45230 |
| 100 | University Hospitals Case Medical Center | Cleveland | Ohio | United States | 44106 |
| 101 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 102 | Nationwide Children's Hospital | Columbus | Ohio | United States | 43205 |
| 103 | The Arthur G. James Cancer Hospital/The Ohio State University Medical Center | Columbus | Ohio | United States | 43210 |
| 104 | University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | United States | 73103 |
| 105 | Oregon Health & Science University/Doernbecher Children's Hospital | Portland | Oregon | United States | 97239 |
| 106 | Penn State Milton S. Hershey Cancer Center | Hershey | Pennsylvania | United States | 17033 |
| 107 | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
| 108 | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15224 |
| 109 | Western Penn Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
| 110 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 111 | University of Pennsylvania/Thomas Jefferson | Pittsburgh | Pennsylvania | United States | 19104 |
| 112 | Roger Williams Medical Center | Providence | Rhode Island | United States | 02908 |
| 113 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 114 | Avera Transplant Institute | Sioux Falls | South Dakota | United States | 57105 |
| 115 | Methodist Healthcare Blood and Marrow Transplant Center | Memphis | Tennessee | United States | 38104 |
| 116 | St. Jude Childrens Research Hospital | Memphis | Tennessee | United States | 38105 |
| 117 | Sarah Cannon BMT Program | Nashville | Tennessee | United States | 37203 |
| 118 | VA Tennessee Valley Healthcare System | Nashville | Tennessee | United States | 37212 |
| 119 | Vanderbilt University | Nashville | Tennessee | United States | 37232 |
| 120 | Amarillo Blood and Marrow Transplant Program | Amarillo | Texas | United States | 79106 |
| 121 | Medical City Dallas | Dallas | Texas | United States | 75230 |
| 122 | Children's Medical Center Dallas | Dallas | Texas | United States | 75235 |
| 123 | University of Texas Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 124 | Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center) | Fort Sam Houston | Texas | United States | 78234 |
| 125 | Cook Children's Hospital | Fort Worth | Texas | United States | 76104 |
| 126 | M.D. Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 127 | Texas Children's Hospital - Baylor Medical Center | Houston | Texas | United States | 77030 |
| 128 | Southwest Cancer Treatment & Research Center | Lubbock | Texas | United States | 79415 |
| 129 | The Children's Hospital of San Antonio | San Antonio | Texas | United States | 78207 |
| 130 | Methodist Healthcare System of San Antonio/Texas Transplant Institute | San Antonio | Texas | United States | 78229 |
| 131 | University of Utah | Salt Lake City | Utah | United States | 84132 |
| 132 | University of Virginia | Charlottesville | Virginia | United States | 22908 |
| 133 | Virginia Commonwealth University | Richmond | Virginia | United States | 23227 |
| 134 | VA Puget Sound HCS | Seattle | Washington | United States | 98108 |
| 135 | Fred Hutchinson Cancer Research Center | Seattle | Washington | United States | 98109 |
| 136 | West Virginia University | Morgantown | West Virginia | United States | 26506-8110 |
| 137 | University of Wisconsin - Madison | Madison | Wisconsin | United States | 53792 |
| 138 | Children's Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 139 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Center for International Blood and Marrow Transplant Research
- National Marrow Donor Program
Investigators
- Study Chair: John Miller, MD, PhD, NMDP/CIBMTR
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT01553461
Other Study ID Numbers:
- 10-CBA
- NCT01553461
First Posted:
May 11, 2011
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Additional relevant MeSH terms: