Cord Blood Transplantation Study (COBLT) - Catalog
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Name
Cord Blood Transplantation Study (COBLT)
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Accession Number
HLB00590707a
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Acronym
COBLT
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Related studies(CBB) NHLBI Umbilical Cord Blood Unit Collection (CBB)
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BSI Study IDs
COBT
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Is public use dataset
False
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Keywords
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Ingestion StatusReleased
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Has Study Datasets
True
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Has Specimens
False
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Specimen ID TypeNot Applicable (Data Only)
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Study Website
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The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.
False
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Clinical Trial URLs
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Study typeEpidemiology Study
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Collection TypeOpen BioLINCC Study
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Cohort typeBoth
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Interventions
Procedure: stem cell transplantation
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Study Open Date (Data)
2009-10-01
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Study Open Date (Specimens)
2017-07-26
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Date materials available
2008-10-13
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Last updated
2017-07-26
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Study period
March 1999 - December 2003
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Study Contacts
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NHLBI Division
DBDR
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ClassificationTransfusion Medicine
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HIV study classificationnon-HIV
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COVID study classificationnon-COVID
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Pre-Website # of Specimens Shipped
101
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# of Returned Specimens
0
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Primary Publication URLs
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Commercial use data restrictionsNo
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Data restrictions based on area of researchNo
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Commercial use specimen restrictionsNot Applicable (Data Only)
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Non-genetic use specimen restrictions based on area of useNot Applicable (Data Only)
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Genetic use of specimens allowed?Not Applicable (Data Only)
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Genetic use area of research restrictionsNot Applicable (No Genetic Use Specimens)
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Specific Consent Restrictions
None
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ConditionsAnemia, Aplastic
Fanconi Anemia
Hematologic Diseases
Hematopoietic Stem Cell Transplantation
Leukemia
Myelodysplastic Syndromes
Neoplasms
Severe Combined Immunodeficiency
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Objectives
The transplant center protocol was a phase II multicenter trial to determine if banked unrelated donor umbilical cord blood could serve as an adequate hematopoietic stem cell source for adults and children with malignancies, immune deficiencies, inherited marrow failure, or inborn errors of metabolism. The largest strata studied pediatric patients with various leukemias. Each participating transplant center used the same patient selection criteria, preparative regimen for patients in the same class, initial graft-versus-host disease (GvHD) prophylaxis, indications for the use of cytokines, definitions for events and complications, and methods for evaluating immune reconstitution. The main study evaluated the impact of HLA 3/6 and 4/6 matching on outcome. The primary endpoint was 180-day disease free survival after UCBU transplantation. Secondary endpoints included engraftment, the frequency and severity of acute and chronic GvHD with stratification by degree of HLA match, overall survival, and immunologic reconstitution. Search activity was initiated in November 1998 and the first UCBU transplant was in March 1999. Enrollment in the COBLT transplant protocol ended December 31, 2003 with the accrual of 364 transplant recipients.
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Background
Compared to other stem cell sources, cord blood is easier and safer to procure, has no donor attrition, a limitless supply, reduced viral transmission, less acute and chronic graft-versus-host-disease, is rich in hematopoietic progenitor cells, and immaturity of T-cell-mediated immunity. However, cord blood also has delayed neutrophil and platelet engraftment, a prolonged immune reconstitution, uncertain graft-versus-tumor activity, and cell doses from single cord blood units are a limiting factor for larger recipients.
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Participants
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Design
The Cord Blood Transplantation (COBLT) Study was comprised of three cord blood banks, seven core transplant centers and a data coordinating center. Funding was initiated in 1996 and the first two years of the project focused on the establishment of three cord blood banks and the development of validated Standard Operating Procedures for the recruitment of cord blood donors and collection, processing, testing and storage of umbilical cord blood units (UCBUs). The transplant protocol and Manual of Procedures for the clinical trial were also developed during this time by the original seven participating transplant centers. Additional centers were recruited to reach accrual goals and the transplant protocol was initiated at 26 participating institutions.
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Conclusions
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Disease classification
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Publications
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Mat types
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Network
The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.
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Subjects
364 Subjects
Last Modified: Jan. 5, 2018, 12:41 p.m. -
Age
Participants' age at transplant by stratum:
STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 years STRATUM: Malignant disease, 4/6 HLA match, <=18 years STRATUM: Malignant disease, 3/6 HLA match, <=18 years STRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromes STRATUM: Inborn errors of metabolism/storage diseases N % N % N % N % N % 1 1.30 1 0.90 . . 1 20.00 1 1.43 Under 1 year 2 2.60 . . . . 1 20.00 18 25.71 1 to 5 36 46.75 28 25.23 . . 3 60.00 44 62.86 6 to 10 23 29.87 43 38.74 4 80.00 . . 6 8.57 11 to 17 15 19.48 39 35.14 1 20.00 . . 1 1.43 18 to 54 . . . . . . . . . . STRATUM: Immunodeficiencies STRATUM: Malignant disease alternative conditioning regimen STRATUM: Adult patients, >18 years All N % N % N % N % . . . . 4 11.76 8 2.20 Under 1 year 12 50.00 9 23.68 . . 42 11.54 1 to 5 10 41.67 23 60.53 . . 144 39.56 6 to 10 2 8.33 3 7.89 . . 81 22.25 11 to 17 . . 3 7.89 . . 59 16.21 18 to 54 . . . . 30 88.24 30 8.24
Last Modified: Nov. 17, 2023, 12:42 p.m. -
Sex
Participants by stratum:
STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 years STRATUM: Malignant disease, 4/6 HLA match, <=18 years STRATUM: Malignant disease, 3/6 HLA match, <=18 years STRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromes STRATUM: Inborn errors of metabolism/storage diseases N % N % N % N % N % Male 40 51.95 75 67.57 2 40.00 3 60.00 45 64.29 Female 37 48.05 36 32.43 3 60.00 2 40.00 25 35.71 STRATUM: Immunodeficiencies STRATUM: Malignant disease alternative conditioning regimen STRATUM: Adult patients, >18 years All N % N % N % N % Male 19 79.17 16 42.11 17 50.00 217 59.62 Female 5 20.83 22 57.89 17 50.00 147 40.38 Donors by stratum:
STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 years STRATUM: Malignant disease, 4/6 HLA match, <=18 years STRATUM: Malignant disease, 3/6 HLA match, <=18 years STRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromes STRATUM: Inborn errors of metabolism/storage diseases N % N % N % N % N % 4 5.19 2 1.80 . . 1 20.00 1 1.43 Male 41 53.25 60 54.05 2 40.00 2 40.00 29 41.43 Female 32 41.56 49 44.14 3 60.00 2 40.00 40 57.14 STRATUM: Immunodeficiencies STRATUM: Malignant disease alternative conditioning regimen STRATUM: Adult patients, >18 years All N % N % N % N % . . 1 2.63 4 11.76 13 3.57 Male 10 41.67 22 57.89 16 47.06 182 50.00 Female 14 58.33 15 39.47 14 41.18 169 46.43
Last Modified: Nov. 17, 2023, 12:42 p.m. -
Race
Participants by stratum:
STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 years STRATUM: Malignant disease, 4/6 HLA match, <=18 years STRATUM: Malignant disease, 3/6 HLA match, <=18 years STRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromes STRATUM: Inborn errors of metabolism/storage diseases N % N % N % N % N % 1 1.30 1 0.90 . . 1 20.00 1 1.43 Black 2 2.60 23 20.72 . . 1 20.00 6 8.57 Other 9 11.69 13 11.71 1 20.00 . . 16 22.86 White 65 84.42 74 66.67 4 80.00 3 60.00 47 67.14 STRATUM: Immunodeficiencies STRATUM: Malignant disease alternative conditioning regimen STRATUM: Adult patients, >18 years All N % N % N % N % 1 4.17 . . 3 8.82 8 2.20 Black 5 20.83 8 21.05 3 8.82 48 13.19 Other 1 4.17 . . 3 8.82 43 11.81 White 17 70.83 30 78.95 25 73.53 265 72.80
Donors by stratum:STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 years STRATUM: Malignant disease, 4/6 HLA match, <=18 years STRATUM: Malignant disease, 3/6 HLA match, <=18 years STRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromes STRATUM: Inborn errors of metabolism/storage diseases N % N % N % N % N % 9 11.69 7 6.31 . . 1 20.00 1 1.43 Black 2 2.60 20 18.02 . . 2 40.00 4 5.71 Other 5 6.49 6 5.41 2 40.00 . . 4 5.71 White 61 79.22 78 70.27 3 60.00 2 40.00 61 87.14 STRATUM: Immunodeficiencies STRATUM: Malignant disease alternative conditioning regimen STRATUM: Adult patients, >18 years All N % N % N % N % 4 16.67 2 5.26 7 20.59 31 8.52 Black 4 16.67 2 5.26 . . 34 9.34 Other 1 4.17 . . 2 5.88 20 5.49 White 15 62.50 34 89.47 25 73.53 279 76.65
Last Modified: Nov. 17, 2023, 12:42 p.m.