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

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

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

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.

Subjects

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

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.