Completed

Phase 2
Age: 0 - 55Years
All Genders
ID00000603

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2016-04-14

N/A

Participants Needed

N/A

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cord Blood Stem Cell Transplantation Study (COBLT)

Who Can Participate

Age: 0 - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.

Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Site Locations not provided

Location information for this trial is currently unavailable.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Banking and transplantation of unrelated donor umbilical cord blood: status of the National Heart, Lung, and Blood Institute-sponsored trial.

J E Wagner, J Kurtzberg

https://pubmed.ncbi.nlm.nih.gov/9738618

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.

Donna A Wall, Shelly L Carter, Nancy A Kernan...

https://pubmed.ncbi.nlm.nih.gov/16041314

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.

Mitchell S Cairo, Elizabeth L Wagner, John Fraser...

https://pubmed.ncbi.nlm.nih.gov/15934982