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
Enrollment
139
Locations
360
Duration (Months)
719.4
Patients Per Site
2
Patients Per Site Per Month

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.

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

ArmIntervention/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

  1. 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.

  2. 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

SiteCityStateCountryPostal Code
1University of Alabama at BirminghamBirminghamAlabamaUnited States35233
2Banner MD Anderson Cancer CenterGilbertArizonaUnited States85234
3Phoenix Children's HospitalPhoenixArizonaUnited States85016
4Mayo Clinic Arizona (adults)PhoenixArizonaUnited States85054
5University of Arizona Medical Center - TucsonTucsonArizonaUnited States85224
6City of HopeDuarteCaliforniaUnited States91010
7Children's Hospital of Los AngelesGlendaleCaliforniaUnited States91204
8Scripps Green HospitalLa JollaCaliforniaUnited States92037
9University of California San DiegoLa JollaCaliforniaUnited States92093
10Loma Linda University Cancer CenterLoma LindaCaliforniaUnited States92350
11UCLALos AngelesCaliforniaUnited States90095
12Children's Hospital and Research Center of OaklandOaklandCaliforniaUnited States94609
13Children's Hospital of Orange County (CHOC)OrangeCaliforniaUnited States92868
14Sutter Medical CenterSacramentoCaliforniaUnited States95816
15Rady Children's Hospital San DiegoSan DiegoCaliforniaUnited States92123
16UCSF (adults)San FranciscoCaliforniaUnited States94143
17UCSF (peds)San FranciscoCaliforniaUnited States94143
18Stanford University Medical CenterStanfordCaliforniaUnited States94304
19Children's Hospital ColoradoAuroraColoradoUnited States80045
20University of Colorado HospitalAuroraColoradoUnited States80045
21Presbyterian St. Luke's/Colorado Blood Cancer InstituteDenverColoradoUnited States80218
22Yale New Haven HospitalNew HavenConnecticutUnited States06510
23Nemours - Alfred I. duPont Hospital for ChildrenBrandywineDelawareUnited States19803
24Children's National Medical CenterWashingtonDistrict of ColumbiaUnited States20010
25University of Florida Shands Medical CenterGainesvilleFloridaUnited States32610
26Nemours Children's Hospital - Mayo JacksonvilleJacksonvilleFloridaUnited States32207
27Mayo Clinic - JacksonvilleJacksonvilleFloridaUnited States32224
28University of Miami (adult)MiamiFloridaUnited States33136
29University of Miami (peds)MiamiFloridaUnited States33136
30Niklaus Children's HospitalMiamiFloridaUnited States33155
31AdventHealth OrlandoOrlandoFloridaUnited States32804
32Florida Center for Pediatric Cellular TherapyOrlandoFloridaUnited States32804
33All Children's HospitalSaint PetersburgFloridaUnited States33701
34H Lee Moffitt Cancer CenterTampaFloridaUnited States33612
35Children's Healthcare of AtlantaAtlantaGeorgiaUnited States30322
36Emory University HospitalAtlantaGeorgiaUnited States30322
37Northside HospitalAtlantaGeorgiaUnited States30342
38Medical College of GeorgiaAugustaGeorgiaUnited States30912
39Kapiolani Medical Center for Women and ChildrenHonoluluHawaiiUnited States96813
40Northwestern Memorial HospitalChicagoIllinoisUnited States60611
41Rush University Medical CenterChicagoIllinoisUnited States60612
42University of Illinois at ChicagoChicagoIllinoisUnited States60612
43Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinoisUnited States60614
44University of ChicagoChicagoIllinoisUnited States60637
45Loyola University Medical CenterMaywoodIllinoisUnited States60153
46Advocate Lutheran General HospitalPark RidgeIllinoisUnited States60068
47Midwestern Regional Medical CenterZionIllinoisUnited States60099
48Indiana Blood & Marrow TransplantationBeech GroveIndianaUnited States46107
49Indiana University/Riley Hospital for ChildrenIndianapolisIndianaUnited States46202
50University of IowaIowa CityIowaUnited States52242
51University of KansasWestwoodKansasUnited States66205
52University of Louisville Hospital - James Brown Cancer CenterLouisvilleKentuckyUnited States40202
53Tulane Medical CenterNew OrleansLouisianaUnited States70112
54Children's Hospital of New Orleans/LSUHSCNew OrleansLouisianaUnited States70118
55Greenebaum Cancer Center - University of MarylandBaltimoreMarylandUnited States21201
56Johns HopkinsBaltimoreMarylandUnited States21287
57Nih/NiaidBethesdaMarylandUnited States20892-1456
58NIH/NCIBethesdaMarylandUnited States20892
59Nih/NhlbiBethesdaMarylandUnited States20892
60Tufts Medical CenterBostonMassachusettsUnited States02111
61Massachusetts General HospitalBostonMassachusettsUnited States02114
62Beth Israel DeaconessBostonMassachusettsUnited States02215
63Dana Farber Cancer InstituteBostonMassachusettsUnited States02215
64University of MassachusettsWorcesterMassachusettsUnited States01655
65University of MichiganAnn ArborMichiganUnited States48109
66Children's Hospital of MichiganDetroitMichiganUnited States48201
67Karmanos Cancer InstituteDetroitMichiganUnited States48201
68Henry Ford Health SystemDetroitMichiganUnited States48202
69Helen DeVos Children's HospitalGrand RapidsMichiganUnited States49503
70Spectrum HealthGrand RapidsMichiganUnited States49503
71Mayo Clinic RochesterRochesterMinnesotaUnited States55905
72Univeristy of Mississippi Medical CenterJacksonMississippiUnited States39216
73Children's Mercy Hospital and ClinicsKansas CityMissouriUnited States64108
74Cardinal Glennon Children's Medical CenterSaint LouisMissouriUnited States63104
75St. Louis University Medical CenterSaint LouisMissouriUnited States63110
76Washington University St. LouisSaint LouisMissouriUnited States63110
77Washington University/St. Louis Children's HospitalSaint LouisMissouriUnited States63110
78University of Nebraska Medical CenterOmahaNebraskaUnited States68198-2168
79Hackensack University Medical CenterHackensackNew JerseyUnited States07601
80Robert Wood Johnson/Cancer Institute of New JerseyNew BrunswickNew JerseyUnited States08901
81Children's Hospital at MontefioreBronxNew YorkUnited States10467
82Roswell Park Cancer InstituteBuffaloNew YorkUnited States14263
83North Shore University HospitalLake SuccessNew YorkUnited States11042
84Cohen Children's Medical Center of New YorkNew Hyde ParkNew YorkUnited States11040
85New York University Langone Medical CenterNew YorkNew YorkUnited States10016
86New York Presbyterian Hospital at CornellNew YorkNew YorkUnited States10021
87Mount Sinai Medical CenterNew YorkNew YorkUnited States10029
88Columbia University Medical Center - Morgan Stanley Children's HospitalNew YorkNew YorkUnited States10032
89Memorial Sloan-Kettering Cancer CenterNew YorkNew YorkUnited States10065
90Westchester Medical CenterNew YorkNew YorkUnited States10595
91Strong Memorial Hospital/University of RochesterRochesterNew YorkUnited States14642-8704
92Stony Brook University HospitalStony BrookNew YorkUnited States11794
93University of North Carolina at Chapel HillChapel HillNorth CarolinaUnited States27599
94Levine Children's HospitalCharlotteNorth CarolinaUnited States28203
95Duke University Medical CenterDurhamNorth CarolinaUnited States27705
96Wake Forest UniversityWinston-SalemNorth CarolinaUnited States27157
97Childrens Hospital Medical Center of AkronAkronOhioUnited States44308
98Cincinnati Children's HospitalCincinnatiOhioUnited States45229
99The Jewish HospitalCincinnatiOhioUnited States45230
100University Hospitals Case Medical CenterClevelandOhioUnited States44106
101Cleveland ClinicClevelandOhioUnited States44195
102Nationwide Children's HospitalColumbusOhioUnited States43205
103The Arthur G. James Cancer Hospital/The Ohio State University Medical CenterColumbusOhioUnited States43210
104University of Oklahoma Health Science CenterOklahoma CityOklahomaUnited States73103
105Oregon Health & Science University/Doernbecher Children's HospitalPortlandOregonUnited States97239
106Penn State Milton S. Hershey Cancer CenterHersheyPennsylvaniaUnited States17033
107Children's Hospital of PhiladelphiaPhiladelphiaPennsylvaniaUnited States19104
108Children's Hospital of PittsburghPittsburghPennsylvaniaUnited States15224
109Western Penn HospitalPittsburghPennsylvaniaUnited States15224
110University of Pittsburgh Medical CenterPittsburghPennsylvaniaUnited States15232
111University of Pennsylvania/Thomas JeffersonPittsburghPennsylvaniaUnited States19104
112Roger Williams Medical CenterProvidenceRhode IslandUnited States02908
113Medical University of South CarolinaCharlestonSouth CarolinaUnited States29425
114Avera Transplant InstituteSioux FallsSouth DakotaUnited States57105
115Methodist Healthcare Blood and Marrow Transplant CenterMemphisTennesseeUnited States38104
116St. Jude Childrens Research HospitalMemphisTennesseeUnited States38105
117Sarah Cannon BMT ProgramNashvilleTennesseeUnited States37203
118VA Tennessee Valley Healthcare SystemNashvilleTennesseeUnited States37212
119Vanderbilt UniversityNashvilleTennesseeUnited States37232
120Amarillo Blood and Marrow Transplant ProgramAmarilloTexasUnited States79106
121Medical City DallasDallasTexasUnited States75230
122Children's Medical Center DallasDallasTexasUnited States75235
123University of Texas Southwestern Medical CenterDallasTexasUnited States75390
124Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)Fort Sam HoustonTexasUnited States78234
125Cook Children's HospitalFort WorthTexasUnited States76104
126M.D. Anderson Cancer CenterHoustonTexasUnited States77030
127Texas Children's Hospital - Baylor Medical CenterHoustonTexasUnited States77030
128Southwest Cancer Treatment & Research CenterLubbockTexasUnited States79415
129The Children's Hospital of San AntonioSan AntonioTexasUnited States78207
130Methodist Healthcare System of San Antonio/Texas Transplant InstituteSan AntonioTexasUnited States78229
131University of UtahSalt Lake CityUtahUnited States84132
132University of VirginiaCharlottesvilleVirginiaUnited States22908
133Virginia Commonwealth UniversityRichmondVirginiaUnited States23227
134VA Puget Sound HCSSeattleWashingtonUnited States98108
135Fred Hutchinson Cancer Research CenterSeattleWashingtonUnited States98109
136West Virginia UniversityMorgantownWest VirginiaUnited States26506-8110
137University of Wisconsin - MadisonMadisonWisconsinUnited States53792
138Children's Hospital of WisconsinMilwaukeeWisconsinUnited States53226
139Medical College of WisconsinMilwaukeeWisconsinUnited States53226

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:
NCT01351545
Other Study ID Numbers:
  • 10-CBA
  • NCT01553461
First Posted:
May 11, 2011
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022

Study Results

No Results Posted as of Mar 18, 2022