Cord Blood Stem Cell Transplantation Study (COBLT) - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000603

Purpose

To evaluate if HLA-mismatched, unrelated-donor umbilical cord blood stem and progenitor cell units (UCBU) offered a clinically acceptable alternative to matched unrelated-donor allogeneic bone marrow for transplantation with 180-day disease free survival as the endpoint. HLA typing was performed using DNA-base high resolution methods to determine HLA alleles. Patients with "true" HLA 3/6 and 4/6 matches were evaluated. In addition, a separate study in adults addressed the problem of limited cell dose and engraftment failure. The study was not planned as a randomized comparative clinical trial. Instead, it is a phase II/III efficacy study.

Condition	Intervention	Phase
Anemia, Aplastic Fanconi Anemia Hematologic Diseases Leukemia Neoplasms Severe Combined Immunodeficiency Hematopoietic Stem Cell Transplantation Myelodysplastic Syndromes	Procedure: stem cell transplantation	Phase II

Genetics Home Reference related topics: adenosine deaminase deficiency X-linked severe combined immunodeficiency

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	September 1996
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Mothers of Infant-donors must complete a medical history form, have an uncomplicated delivery, and deliver at UCLA or Duke.

Patients are those who need a transplant but don't have a matched marrow donor or can't wait to find one.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000603

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:	Shelly Carter	The EMMES Corporation
Investigator:	Joanne Kurtzberg	Duke University

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

Wagner JE, Kurtzberg J. Banking and transplantation of unrelated donor umbilical cord blood: status of the National Heart, Lung, and Blood Institute-sponsored trial. Transfusion. 1998 Sep;38(9):807-9. Review. No abstract available.

Fraser JK, Cairo MS, Wagner EL, McCurdy PR, Baxter-Lowe LA, Carter SL, Kernan NA, Lill MC, Slone V, Wagner JE, Wallas CH, Kurtzberg J. Cord Blood Transplantation Study (COBLT): cord blood bank standard operating procedures. J Hematother. 1998 Dec;7(6):521-61. Review.

Laughlin MJ, Barker J, Bambach B, Koc ON, Rizzieri DA, Wagner JE, Gerson SL, Lazarus HM, Cairo M, Stevens CE, Rubinstein P, Kurtzberg J. Hematopoietic engraftment and survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl J Med. 2001 Jun 14;344(24):1815-22.

Barker JN, Wagner JE. Umbilical cord blood transplantation: current practice and future innovations. Crit Rev Oncol Hematol. 2003 Oct;48(1):35-43.

Staba SL, Escolar ML, Poe M, Kim Y, Martin PL, Szabolcs P, Allison-Thacker J, Wood S, Wenger DA, Rubinstein P, Hopwood JJ, Krivit W, Kurtzberg J. Cord-blood transplants from unrelated donors in patients with Hurler's syndrome. N Engl J Med. 2004 May 6;350(19):1960-9.

Laughlin MJ, Eapen M, Rubinstein P, Wagner JE, Zhang MJ, Champlin RE, Stevens C, Barker JN, Gale RP, Lazarus HM, Marks DI, van Rood JJ, Scaradavou A, Horowitz MM. Outcomes after transplantation of cord blood or bone marrow from unrelated donors in adults with leukemia. N Engl J Med. 2004 Nov 25;351(22):2265-75.

Cornetta K, Laughlin M, Carter S, Wall D, Weinthal J, Delaney C, Wagner J, Sweetman R, McCarthy P, Chao N. Umbilical cord blood transplantation in adults: results of the prospective Cord Blood Transplantation (COBLT). Biol Blood Marrow Transplant. 2005 Feb;11(2):149-60.

Wall DA, Carter SL, Kernan NA, Kapoor N, Kamani NR, Brochstein JA, Frangoul H, Goyal RK, Horan JT, Pietryga D, Wagner JE, Kurtzberg J. Busulfan/Melphalan/Antithymocyte Globulin Followed by Unrelated Donor Cord Blood Transplantation for Treatment of Infant Leukemia and Leukemia in Young Children: The Cord Blood Transplantation Study (COBLT) Experience. Biol Blood Marrow Transplant. 2005 Aug;11(8):637-46.

Cairo MS, Wagner EL, Fraser J, Cohen G, van de Ven C, Carter SL, Kernan NA, Kurtzberg J. Characterization of banked umbilical cord blood hematopoietic progenitor cells and lymphocyte subsets and correlation with ethnicity, birth weight, sex, and type of delivery: a Cord Blood Transplantation (COBLT) Study report. Transfusion. 2005 Jun;45(6):856-66.

Kurtzberg J, Cairo MS, Fraser JK, Baxter-Lowe L, Cohen G, Carter SL, Kernan NA. Results of the cord blood transplantation (COBLT) study unrelated donor banking program. Transfusion. 2005 Jun;45(6):842-55.

Publications indexed to this study:

Kurtzberg J, Prasad VK, Carter SL, Wagner JE, Baxter-Lowe LA, Wall D, Kapoor N, Guinan EC, Feig SA, Wagner EL, Kernan NA; COBLT Steering Committee. Results of the Cord Blood Transplantation Study (COBLT): clinical outcomes of unrelated donor umbilical cord blood transplantation in pediatric patients with hematologic malignancies. Blood. 2008 Nov 15;112(10):4318-27. Epub 2008 Aug 21.

Study ID Numbers:	316
Study First Received:	October 27, 1999
Last Updated:	January 18, 2008
ClinicalTrials.gov Identifier:	NCT00000603
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Myelodysplastic syndromes
Metabolic Diseases
Precancerous Conditions
Hematologic Diseases
Severe Combined Immunodeficiency
Fanconi Anemia
Myelodysplasia
Myelodysplastic Syndromes
Anemia
Immunologic Deficiency Syndromes

Leukemia
Preleukemia
Fanconi's anemia
Genetic Diseases, Inborn
Anemia, Aplastic
Infant, Newborn, Diseases
Severe combined immunodeficiency
Metabolic disorder
Aplastic anemia
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Disease
Neoplasms by Histologic Type

Anemia, Hypoplastic, Congenital
Immune System Diseases
Syndrome
DNA Repair-Deficiency Disorders

ClinicalTrials.gov processed this record on January 15, 2009