LeukemiaEarly Phase 1NCT00212407
New York Blood Center National Cord Blood Program
A Early Phase 1 study testing Umbilical Cord Blood Transplantation in people with Leukemia and Lymphoma, run by New York Blood Center at 1 site in United States.
Trial summary
Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia, Lymphoma, Genetic Disease
- What is being tested?
- Umbilical Cord Blood Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,476 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1993to 10 Nov 2011
- Phase
- Early Phase 1
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidates for bone marrow transplantation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.
Read the detailed description
Umbilical cord blood donated to the New York Blood Center's National Cord Blood Program is collect, tested, processed, cryoprotected and frozen in liquid nitrogen for possible future transplantation to anyone who needs it. The Program has operated under a FDA IND exemption since 1996 and is licensed as a tissue bank by the New York State Department of Health.
Candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor. Most patients are those with high risk of refractory leukemia, lymphoma, myelodysplasia, severe aplastic anemia and certain genetic hematologic, immunologic and metabolic diseases.
Patients are treated at bone marrow transplant centers in the United States and in other countries with active marrow transplant programs. Because the NYBC Program operates under IND, patients must sign an informed consent for cord blood transplantation.
Transplant centers report on the transplant procedure (including immediate complications) and on transplant outcome at 3, 6 and 12 months post-transplant and annually thereafter. Data report to the New York Blood Center includes information about the patient's disease and pre-transplant conditioning regimen and post-transplant endpoints, primarily myeloid and platelet engraftment, transplant related mortality, overall survival, acute and chronic graft vs. host disease, relapse and other post-transplant complications such as infectious disease. The outcome data is used to assess safety and efficacy and will be used to apply for a license from the FDA.
- Conditions
- Leukemia, Lymphoma, Genetic Disease, Severe Aplastic Anemia, Myelodysplasia
- Being tested
- Umbilical Cord Blood Transplantation
- Keywords
- Cord blood transplantation, bone marrow transplantation
- Medical subject headings
- Leukemia, Lymphoma, Genetic Diseases, Inborn, Anemia, Aplastic, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Blood TransplantationBiological
Also called One or more matched umbilical cord blood units for transplant
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord blood unit(s) transplant | Experimental | Transplantation of cryopreserved umbilical cord blood unit(s) Receives: Biological: Umbilical Cord Blood Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engraftment
Measured: released prior to 12-1-2012
Treatment Related Mortality
Measured: released prior to 12-1-2012
Survival
Measured: released prior to 12-1-2012
Secondary outcomes (2)
Graft vs. Host Disease
Measured: released prior to 12-1-2012
Relapse
Measured: released prior to 12-1-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startFeb 1993
- Primary completion10 Nov 2011
- Study completion10 Nov 2011
Why it stopped: Study NCT01656603 supersedes this study; FDA IND 6637
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,476 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Blood Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Rubinstein, M.D., Principal investigator, New York Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212407
- Sponsor's protocol ID
- 234
- Status last verified
- Oct 2018
- First submitted
- 13 Sep 2005
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New York Blood Center National Cord Blood Program
- ClinicalTrials.gov ID
- NCT00212407
- Acronym / sponsor ID
- 234
- Conditions
- Leukemia, Lymphoma, Genetic Disease, Severe Aplastic Anemia, Myelodysplasia
- Keywords
- Cord blood transplantation, bone marrow transplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study NCT01656603 supersedes this study; FDA IND 6637
- Enrolment
- 4,476 participants (actual)
- Lead sponsor
- New York Blood CenterUniversity, hospital or other
- Study start
- Feb 1993
- Primary completion
- 10 Nov 2011 (actual)
- Study completion
- 10 Nov 2011 (actual)
- First posted
- 21 Sep 2005 (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.
Umbilical cord blood is used as a source of hematopoietic stem cells for bone marrow reconstitution in patients who would be potential candidates for a bone marrow transplant from an unrelated marrow donor. The outcome of transplantation is obtained to assess cord blood myeloid and platelet engraftment, transplant related mortality, overall survival, graft vs. host disease and, for patients with leukemia, lymphoma or myelodysplasia, relapse.
Detailed description
Umbilical cord blood donated to the New York Blood Center's National Cord Blood Program is collect, tested, processed, cryoprotected and frozen in liquid nitrogen for possible future transplantation to anyone who needs it. The Program has operated under a FDA IND exemption since 1996 and is licensed as a tissue bank by the New York State Department of Health.
Candidates for transplant are patients who disease requires bone marrow transplantation but who do not have a suitable related bone marrow donor. Most patients are those with high risk of refractory leukemia, lymphoma, myelodysplasia, severe aplastic anemia and certain genetic hematologic, immunologic and metabolic diseases.
Patients are treated at bone marrow transplant centers in the United States and in other countries with active marrow transplant programs. Because the NYBC Program operates under IND, patients must sign an informed consent for cord blood transplantation.
Transplant centers report on the transplant procedure (including immediate complications) and on transplant outcome at 3, 6 and 12 months post-transplant and annually thereafter. Data report to the New York Blood Center includes information about the patient's disease and pre-transplant conditioning regimen and post-transplant endpoints, primarily myeloid and platelet engraftment, transplant related mortality, overall survival, acute and chronic graft vs. host disease, relapse and other post-transplant complications such as infectious disease. The outcome data is used to assess safety and efficacy and will be used to apply for a license from the FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord blood unit(s) transplant | Experimental | Biological: Umbilical Cord Blood TransplantationTransplantation of cryopreserved umbilical cord blood unit(s) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates for bone marrow transplantation
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 |
|---|---|---|
| Umbilical Cord Blood TransplantationAlso: One or more matched umbilical cord blood units for transplant | Biological | Umbilical cord blood unit(s) transplant |
Primary outcome
Engraftment
Time frame: released prior to 12-1-2012
Treatment Related Mortality
Time frame: released prior to 12-1-2012
Survival
Time frame: released prior to 12-1-2012
2 secondary outcomes
Graft vs. Host Disease
Time frame: released prior to 12-1-2012
Relapse
Time frame: released prior to 12-1-2012
Results and safety
The study was stopped early (reason given: Study NCT01656603 supersedes this study; FDA IND 6637). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Click here for more information about the New York Blood Center National Cord Blood ProgramLink provided by the sponsor.
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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.
Pablo Rubinstein, M.D. principal investigator
New York Blood Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Umbilical Cord Blood Transplantation in people with Leukemia and Lymphoma, run by New York Blood Center at 1 site 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: stopped early, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Study NCT01656603 supersedes this study; FDA IND 6637). Results are not available in the source record.
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?
Engraftment (time frame: released prior to 12-1-2012). The study lists 3 primary outcomes in all. 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 2 Nov 2018.