Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Cord Blood Stem Cell Transplantation Study (COBLT)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000603
First received: October 27, 1999
Last updated: January 18, 2008
Last verified: January 2008
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Investigators
Investigator: Shelly Carter The EMMES Corporation
Investigator: Joanne Kurtzberg Duke University
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000603     History of Changes
Other Study ID Numbers: 316
Study First Received: October 27, 1999
Last Updated: January 18, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Severe Combined Immunodeficiency
Anemia
Anemia, Aplastic
Fanconi Anemia
Fanconi Syndrome
Hematologic Diseases
Immunologic Deficiency Syndromes
Myelodysplastic Syndromes
Preleukemia
Anemia, Hypoplastic, Congenital
Bone Marrow Diseases
DNA Repair-Deficiency Disorders
Genetic Diseases, Inborn
Immune System Diseases
Infant, Newborn, Diseases
Kidney Diseases
Metabolic Diseases
Metabolism, Inborn Errors
Neoplasms
Precancerous Conditions
Renal Tubular Transport, Inborn Errors
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014