NCT00737516

Brief Summary

The National Marrow Donor Program (NMDP) has established a system for registering, matching, and tracking unrelated donor cord blood units (CBUs) and transplant outcomes. Study subjects are donors who enroll through collaborating cord blood banks. This study creates uniform collection, screening, testing and storage requirements for cord blood units. The purpose of standardization is to improve efficiency in the selection of cord blood units for transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,621

participants targeted

Target at P75+ for phase_2 leukemia

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_2 leukemia

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

11.8 years

First QC Date

August 15, 2008

Last Update Submit

June 12, 2013

Conditions

Keywords

RegistryUnrelated Umbilical Cord Blood donorHematopoietic ReconstitutionCenter for Cord BloodBone Marrow Transplantation

Outcome Measures

Primary Outcomes (1)

  • Study safety and efficacy for treatment for malignant and non-malignant disorders

    annually

Secondary Outcomes (1)

  • Study relationship between HLA disparity and survival

    annually

Study Arms (1)

single arm

EXPERIMENTAL

HPC, Cord Blood

Biological: HPC, Cord Blood

Interventions

HPC, Cord BloodBIOLOGICAL

Search for HLA compatible cord blood units using the NMDP registry

single arm

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

StemCyte International Cord Blood Center

Covina, California, 91722, United States

Location

Children's Hospital of Orange County Cord Blood Bank

Orange, California, 92868, United States

Location

Ashley Ross Cord Blood Program

San Diego, California, 92103, United States

Location

University of Colorado Cord Blood Bank

Aurora, Colorado, 80218, United States

Location

Bonfils Cord Blood Service

Denver, Colorado, 80230, United States

Location

Lifeforce Cryobanks

Altamonte Springs, Florida, 32701, United States

Location

Gift of Life Marrow Foundation

Boca Raton, Florida, 33431, United States

Location

LifeCord

Gainesville, Florida, 32607, United States

Location

ITxM Cord Blood Services

Glenview, Illinois, 60025, United States

Location

J.P. McMarthy Cord Stem Cell Bank

Detroit, Michigan, 48201, United States

Location

Michigan Community Blood Centers

Grand Rapids, Michigan, 49503, United States

Location

St. Louis Cord Blood Bank

St Louis, Missouri, 63110, United States

Location

CBS - New Jersey Cord Blood bank

Allendale, New Jersey, 07401, United States

Location

Coriell - New Jersey Cord Blood Bank

Camden, New Jersey, 08103, United States

Location

Carolinas Cord Blood Bank

Durham, North Carolina, 27710, United States

Location

Cleveland Cord Blood Center

Cleveland, Ohio, 44128, United States

Location

M.D. Anderson Cord Blood Bank

Houston, Texas, 77030, United States

Location

Texas Cord Blood Bank

San Antonio, Texas, 78201, United States

Location

Puget Sound Blood Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaMyelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow Diseases

Study Officials

  • John P Miller, M.D., Ph.D.

    National Marrow Donor Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2008

First Posted

August 19, 2008

Study Start

January 1, 2000

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations