Hematologic NeoplasmsPhase 1/2NCT00312429
Umbilical Cord Blood Stem Cell Transplantation in Adults With Advanced Blood Disorders or Cancer
A Phase 1/2 study testing Stem Cell Transplantation in people with Hematologic Neoplasms, run by Duke University at 1 site in United States.
Trial summary
Umbilical cord blood is an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have been shown to be effective in treating illness in children, but more research is needed to confirm the benefit of this… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- Stem Cell Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to May 2008
- Phase
- Phase 1/2
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis reviewed at transplant center and confirmed to fit the criterion for high risk blood disease or cancer, as defined for the study
- Estimated life expectancy of at least 6 weeks following study entry
- Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2
- White blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results reviewed by transplant center
- Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT) performed and reviewed by transplant center (for individuals with an ejection fraction and diffusing capacity [DLCO] of 40-50%, the appropriate cardiology or pulmonary consultations should be considered if the individual has severe heart or lung disease at the initiation of therapy)
- Sufficient number of umbilical cord blood units available for transplantation
- If female, willing to use contraception throughout the study
Who cannot join
- Undergoing Interleukin-2 (IL-2) therapy within 8 weeks of study entry
- Diagnosed with a medical or psychiatric illness that may interfere with study participation
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cord Blood Transplantation in Adult Recipients
Umbilical cord blood is an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have been shown to be effective in treating illness in children, but more research is needed to confirm the benefit of this procedure in adults. The purpose of this study is to examine the immune system response to cord blood stem cell transplantation in adults with advanced blood disorders or cancer.
Read the detailed description
The use of umbilical cord blood stem cells to treat blood disorders and cancer is an important medical advance; currently, more than 45 disorders can be treated with this method. While bone marrow transplants are the most common method for stem cell donations, research has shown that there are many advantages to using allogeneic grafts of stem cells obtained from umbilical cord blood. Cord blood stem cells are relatively easy to obtain. Additionally, a perfect donor match is not necessary, thereby decreasing the likelihood of graft-versus-host disease (GVHD), a serious side effect in which donor stem cells attack the recipient's tissues. Cord blood has been used successfully in pediatric patients but its benefit in adults remains untested. The purpose of this study is to evaluate the effectiveness of umbilical cord blood stem cell transplantation in adults with advanced blood disorders or cancer. Upon receiving an allogeneic stem cell transplant using umbilical cord blood, participants will be observed for successful engraftment in which the transplanted stem cells "take" and begin producing new blood cells. The incidence of GVHD and the overall immune system's response will also be examined. In turn, these findings may guide future umbilical cord blood stem cell clinical trials.
This 1-year study will enroll individuals with advanced blood diseases or cancer. Participants will receive an allogeneic umbilical cord blood stem cell transplant and will be closely monitored while in the hospital to determine when engraftment occurs and if GVHD develops. Study visits will occur at Months 1, 2, 3, 6, 9, and Year 1. At each visit, participants will have blood drawn for laboratory testing and for evaluation of immune system response. Quality of life questionnaires will also be completed at each visit.
- Conditions
- Hematologic Neoplasms
- Being tested
- Stem Cell Transplantation
- Keywords
- Hematological Malignancies, Leukemia, Lymphoma, Myelodysplasia, Multiple Myeloma
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Lymphoma, Anemia, Refractory, with Excess of Blasts, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cell TransplantationProcedure or surgery
Allogeneic umbilical cord blood stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startJan 2002
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nelson J. Chao, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312429
- Sponsor's protocol ID
- 2166
- Other IDs
- R01HL062095-06
- Status last verified
- Apr 2012
- First submitted
- 6 Apr 2006
- Last updated
- 3 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cord Blood Transplantation in Adult Recipients
- ClinicalTrials.gov ID
- NCT00312429
- Acronym / sponsor ID
- 2166
- Conditions
- Hematologic Neoplasms
- Keywords
- Hematological Malignancies, Leukemia, Lymphoma, Myelodysplasia, Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2002
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Apr 2006 (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 an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have been shown to be effective in treating illness in children, but more research is needed to confirm the benefit of this procedure in adults. The purpose of this study is to examine the immune system response to cord blood stem cell transplantation in adults with advanced blood disorders or cancer.
Detailed description
The use of umbilical cord blood stem cells to treat blood disorders and cancer is an important medical advance; currently, more than 45 disorders can be treated with this method. While bone marrow transplants are the most common method for stem cell donations, research has shown that there are many advantages to using allogeneic grafts of stem cells obtained from umbilical cord blood. Cord blood stem cells are relatively easy to obtain. Additionally, a perfect donor match is not necessary, thereby decreasing the likelihood of graft-versus-host disease (GVHD), a serious side effect in which donor stem cells attack the recipient's tissues. Cord blood has been used successfully in pediatric patients but its benefit in adults remains untested. The purpose of this study is to evaluate the effectiveness of umbilical cord blood stem cell transplantation in adults with advanced blood disorders or cancer. Upon receiving an allogeneic stem cell transplant using umbilical cord blood, participants will be observed for successful engraftment in which the transplanted stem cells "take" and begin producing new blood cells. The incidence of GVHD and the overall immune system's response will also be examined. In turn, these findings may guide future umbilical cord blood stem cell clinical trials.
This 1-year study will enroll individuals with advanced blood diseases or cancer. Participants will receive an allogeneic umbilical cord blood stem cell transplant and will be closely monitored while in the hospital to determine when engraftment occurs and if GVHD develops. Study visits will occur at Months 1, 2, 3, 6, 9, and Year 1. At each visit, participants will have blood drawn for laboratory testing and for evaluation of immune system response. Quality of life questionnaires will also be completed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis reviewed at transplant center and confirmed to fit the criterion for high risk blood disease or cancer, as defined for the study
- Estimated life expectancy of at least 6 weeks following study entry
- Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2
- White blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results reviewed by transplant center
- Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT) performed and reviewed by transplant center (for individuals with an ejection fraction and diffusing capacity [DLCO] of 40-50%, the appropriate cardiology or pulmonary consultations should be considered if the individual has severe heart or lung disease at the initiation of therapy)
Key exclusion criteria (3 listed)
- Undergoing Interleukin-2 (IL-2) therapy within 8 weeks of study entry
- Diagnosed with a medical or psychiatric illness that may interfere with study participation
- Pregnant
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 |
|---|---|---|
| Stem Cell TransplantationAllogeneic umbilical cord blood stem cell transplant | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
1 secondary outcome
Survival Rates
Time frame: Year 1
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 3 Apr 2012.
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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.
Nelson J. Chao, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stem Cell Transplantation in people with Hematologic Neoplasms, run by Duke University 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 7 inclusion and 3 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 3 Apr 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 3 Apr 2012.