LeukemiaPhase 2NCT00737516
Centralized Cord Blood Registry to Facilitate Unrelated Cord Blood Transplantation
A Phase 2 study testing HPC, Cord Blood in people with Leukemia and Lymphoma, run by National Marrow Donor Program at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- What is being tested?
- HPC, Cord Blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,621 participants
- Where
- 19 sitesUnited States
- Study dates
- Jan 2000to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnancy
Who cannot join
- -
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
CBS - New Jersey Cord Blood bank
Allendale, New Jersey, 07401
Lifeforce Cryobanks
Altamonte Springs, Florida, 32701
University of Colorado Cord Blood Bank
Aurora, Colorado, 80218
Gift of Life Marrow Foundation
Boca Raton, Florida, 33431
Coriell - New Jersey Cord Blood Bank
Camden, New Jersey, 08103
Cleveland Cord Blood Center
Cleveland, Ohio, 44128
StemCyte International Cord Blood Center
Covina, California, 91722
Bonfils Cord Blood Service
Denver, Colorado, 80230
J.P. McMarthy Cord Stem Cell Bank
Detroit, Michigan, 48201
Carolinas Cord Blood Bank
Durham, North Carolina, 27710
LifeCord
Gainesville, Florida, 32607
ITxM Cord Blood Services
Glenview, Illinois, 60025
Michigan Community Blood Centers
Grand Rapids, Michigan, 49503
M.D. Anderson Cord Blood Bank
Houston, Texas, 77030
Children's Hospital of Orange County Cord Blood Bank
Orange, California, 92868
Texas Cord Blood Bank
San Antonio, Texas, 78201
Ashley Ross Cord Blood Program
San Diego, California, 92103
Puget Sound Blood Center
Seattle, Washington, 98104
St. Louis Cord Blood Bank
St Louis, Missouri, 63110
About this study
Official title: A Centralized Cord Blood Registry to Facilitate Allogeneic, Unrelated Donor Umbilical Cord Blood Transplantation
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.
Read the detailed description
The NMDP Cord Blood registry is organized as a network of member cord blood banks and transplant centers whose interactions are managed by the NMDP's Center for Cord Blood. Banks agree to comply with uniform collection, screening, testing and storage requirements. Upon approval of membership, cord blood banks submit detailed information on each stored CBU for registration into a proprietary computer system. A transplant center, working on behalf of potential recipients, submits search requests to the NMDP and receives electronic reports detailing potentially suitable CBUs. From these reports, the transplant center selects a CBU(s) for further testing, which includes at a minimum confirmation of the CBUs Human Leukocyte Antigen (HLA) typing data. Upon final selection of the desired CBU for transplantation, arrangements are made for timely shipment of the unit to the transplant center. Following transplantation, recipient outcome data are submitted by the transplant center for addition to the study database.
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- Being tested
- HPC, Cord Blood
- Keywords
- Registry, Unrelated Umbilical Cord Blood donor, Hematopoietic Reconstitution, Center for Cord Blood, Bone Marrow Transplantation
- Medical subject headings
- Leukemia, Lymphoma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPC, Cord BloodBiological
Search for HLA compatible cord blood units using the NMDP registry
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | HPC, Cord Blood Receives: Biological: HPC, Cord Blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study safety and efficacy for treatment for malignant and non-malignant disorders
Measured: annually
Secondary outcomes (1)
Study relationship between HLA disparity and survival
Measured: annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startJan 2000
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,621 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Marrow Donor Program
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John P Miller, M.D., Ph.D., Principal investigator, National Marrow Donor Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737516
- Sponsor's protocol ID
- T00004
- Status last verified
- Jun 2013
- First submitted
- 15 Aug 2008
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Centralized Cord Blood Registry to Facilitate Allogeneic, Unrelated Donor Umbilical Cord Blood Transplantation
- ClinicalTrials.gov ID
- NCT00737516
- Acronym / sponsor ID
- T00004
- Conditions
- Leukemia, Lymphoma, Myelodysplastic Syndromes
- Keywords
- Registry, Unrelated Umbilical Cord Blood donor, Hematopoietic Reconstitution, Center for Cord Blood, Bone Marrow Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,621 participants (actual)
- Lead sponsor
- National Marrow Donor ProgramUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The NMDP Cord Blood registry is organized as a network of member cord blood banks and transplant centers whose interactions are managed by the NMDP's Center for Cord Blood. Banks agree to comply with uniform collection, screening, testing and storage requirements. Upon approval of membership, cord blood banks submit detailed information on each stored CBU for registration into a proprietary computer system. A transplant center, working on behalf of potential recipients, submits search requests to the NMDP and receives electronic reports detailing potentially suitable CBUs. From these reports, the transplant center selects a CBU(s) for further testing, which includes at a minimum confirmation of the CBUs Human Leukocyte Antigen (HLA) typing data. Upon final selection of the desired CBU for transplantation, arrangements are made for timely shipment of the unit to the transplant center. Following transplantation, recipient outcome data are submitted by the transplant center for addition to the study database.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: HPC, Cord BloodHPC, Cord Blood |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnancy
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPC, Cord BloodSearch for HLA compatible cord blood units using the NMDP registry | Biological | single arm |
Primary outcome
Study safety and efficacy for treatment for malignant and non-malignant disorders
Time frame: annually
1 secondary outcome
Study relationship between HLA disparity and survival
Time frame: annually
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Miller, M.D., Ph.D. principal investigator
National Marrow Donor Program
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HPC, Cord Blood in people with Leukemia and Lymphoma, run by National Marrow Donor Program at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study safety and efficacy for treatment for malignant and non-malignant disorders (time frame: annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.