Cord Blood Transplantation Study (COBLT) - Catalog

  • Name

    Cord Blood Transplantation Study (COBLT)

  • Accession Number

    HLB00590707a

  • Acronym

    COBLT

  • Related studies
    (CBB) NHLBI Umbilical Cord Blood Unit Collection (CBB)
  • BSI Study IDs

    COBT

  • Is public use dataset

    False

  • Keywords
  • Ingestion Status
    Released
  • Has Study Datasets

    True

  • Has Specimens

    False

  • Specimen ID Type
    Not Applicable (Data Only)
  • Study Website
  • 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

  • Clinical Trial URLs
  • Study type
    Epidemiology Study
  • Collection Type
    Open BioLINCC Study
  • Cohort type
    Both
  • Interventions

    Procedure: stem cell transplantation

  • Study Open Date (Data)

    2009-10-01

  • Study Open Date (Specimens)

    2017-07-26

  • Date materials available

    2008-10-13

  • Last updated

    2017-07-26

  • Study period

    March 1999 - December 2003

  • Study Contacts
  • NHLBI Division

    DBDR

  • Classification
    Transfusion Medicine
  • HIV study classification
    non-HIV
  • COVID study classification
    non-COVID
  • Pre-Website # of Specimens Shipped

    101

  • # of Returned Specimens

    0

  • Primary Publication URLs
  • Conditions
    Anemia, Aplastic
    Fanconi Anemia
    Hematologic Diseases
    Hematopoietic Stem Cell Transplantation
    Leukemia
    Myelodysplastic Syndromes
    Neoplasms
    Severe Combined Immunodeficiency
  • 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.

  • 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.

  • Participants
  • 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.

  • Conclusions
  • Disease classification
  • Publications
  • Mat types
  • Network

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • 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 yearsSTRATUM: Malignant disease, 4/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 3/6 HLA match, <=18 yearsSTRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromesSTRATUM: Inborn errors of metabolism/storage diseases
    N%N%N%N%N%
     11.3010.90..120.0011.43
    Under 1 year22.60....120.001825.71
    1 to 53646.752825.23..360.004462.86
    6 to 102329.874338.74480.00..68.57
    11 to 171519.483935.14120.00..11.43
    18 to 54..........

     

     STRATUM: ImmunodeficienciesSTRATUM: Malignant disease alternative conditioning regimenSTRATUM: Adult patients, >18 yearsAll
    N%N%N%N%
     ....411.7682.20
    Under 1 year1250.00923.68..4211.54
    1 to 51041.672360.53..14439.56
    6 to 1028.3337.89..8122.25
    11 to 17..37.89..5916.21
    18 to 54....3088.24308.24

    Last Modified: Nov. 17, 2023, 12:42 p.m.
  • Sex

    Participants by stratum:

     

     STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 4/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 3/6 HLA match, <=18 yearsSTRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromesSTRATUM: Inborn errors of metabolism/storage diseases
    N%N%N%N%N%
    Male4051.957567.57240.00360.004564.29
    Female3748.053632.43360.00240.002535.71

     

     STRATUM: ImmunodeficienciesSTRATUM: Malignant disease alternative conditioning regimenSTRATUM: Adult patients, >18 yearsAll
    N%N%N%N%
    Male1979.171642.111750.0021759.62
    Female520.832257.891750.0014740.38

    Donors by stratum:

     STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 4/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 3/6 HLA match, <=18 yearsSTRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromesSTRATUM: Inborn errors of metabolism/storage diseases
    N%N%N%N%N%
     45.1921.80..120.0011.43
    Male4153.256054.05240.00240.002941.43
    Female3241.564944.14360.00240.004057.14
     STRATUM: ImmunodeficienciesSTRATUM: Malignant disease alternative conditioning regimenSTRATUM: Adult patients, >18 yearsAll
    N%N%N%N%
     ..12.63411.76133.57
    Male1041.672257.891647.0618250.00
    Female1458.331539.471441.1816946.43

     


    Last Modified: Nov. 17, 2023, 12:42 p.m.
  • Race

    Participants by stratum:

     STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 4/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 3/6 HLA match, <=18 yearsSTRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromesSTRATUM: Inborn errors of metabolism/storage diseases
    N%N%N%N%N%
     11.3010.90..120.0011.43
    Black22.602320.72..120.0068.57
    Other911.691311.71120.00..1622.86
    White6584.427466.67480.00360.004767.14

     

     STRATUM: ImmunodeficienciesSTRATUM: Malignant disease alternative conditioning regimenSTRATUM: Adult patients, >18 yearsAll
    N%N%N%N%
     14.17..38.8282.20
    Black520.83821.0538.824813.19
    Other14.17..38.824311.81
    White1770.833078.952573.5326572.80


    Donors by stratum:

     STRATUM: Malignant disease, 5/6 or 6/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 4/6 HLA match, <=18 yearsSTRATUM: Malignant disease, 3/6 HLA match, <=18 yearsSTRATUM: Severe aplastic anemia, Fanconi anemia and other marrow failure syndromesSTRATUM: Inborn errors of metabolism/storage diseases
    N%N%N%N%N%
     911.6976.31..120.0011.43
    Black22.602018.02..240.0045.71
    Other56.4965.41240.00..45.71
    White6179.227870.27360.00240.006187.14

     

     STRATUM: ImmunodeficienciesSTRATUM: Malignant disease alternative conditioning regimenSTRATUM: Adult patients, >18 yearsAll
    N%N%N%N%
     416.6725.26720.59318.52
    Black416.6725.26..349.34
    Other14.17..25.88205.49
    White1562.503489.472573.5327976.65


     


    Last Modified: Nov. 17, 2023, 12:42 p.m.