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Cord Blood Transplantation Study (COBLT) - Catalog
Cord Blood Transplantation Study (COBLT)
HLB00590707a
COBLT
(CBB) NHLBI Umbilical Cord Blood Unit Collection (CBB)
COBT
False
True
False
Not Applicable (Data Only)
False
Epidemiology Study
Open BioLINCC Study
Both
Procedure: stem cell transplantation
2009-10-01
2017-07-26
2008-10-13
2017-07-26
March 1999 - December 2003
DBDR
Transfusion Medicine
non-HIV
non-COVID
101
0
No
No
Not Applicable (Data Only)
Not Applicable (Data Only)
Not Applicable (Data Only)
Not Applicable (No Genetic Use Specimens)
None
Anemia, Aplastic
Fanconi Anemia
Hematologic Diseases
Hematopoietic Stem Cell Transplantation
Leukemia
Myelodysplastic Syndromes
Neoplasms
Severe Combined Immunodeficiency
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.
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.
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.
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.