Acute Lymphocytic LeukemiaPhase 1/2NCT00089596
Infusion of Specially Treated Umbilical Cord Stem Cells After Chemoradiation Treatment for Blood Cancers
A Phase 1/2 study testing Expansion of umbilical cord stem cells in people with Acute Lymphocytic Leukemia and Acute Myeloid Leukemia, run by ViaCell at 4 sites in United States.
Trial summary
This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Expansion of umbilical cord stem cells
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2004to Oct 2006
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Do not have identical or 5/6 related matched bone marrow, peripheral blood or umbilical cord
- Stable disease and lack of unrelated donor
- Acute myeloid leukemia (AML) in 2nd or subsequent complete remission or first remission with high risk features
- ALL in 2nd or subsequent remission or first remission with high risk features
- Myelodysplastic syndrome (MDS)
- Non-Hodgkin Lymphoma (NHL)
- Chronic Myelogenous Leukemia (CML)
- Adequate function of heart, liver, kidneys and lungs
Who cannot join
- Females who are pregnant
- Poor ability to perform daily activities
- Weight under 40 kilograms (88 pounds)
- AML caused by chemoradiation
- Prior stem cell transplant
- Uncontrolled infection at time of transplant
Show all 11Show fewer
- Active fungal infection
- HIV infection
- Primary myelofibrosis
- Receiving other research drugs
- Unable to provide informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
Official title: A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation
This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells that are needed to make the different types of cells in their blood, including their immune system cells. These cells must be replaced in order for the blood and immune systems to work properly. Some people receive bone marrow transplants or other types of stem cell transplants to get the cells they need. CB001 is being developed as an option for people who need bone marrow transplants or other types of transplants to replace those cells. It is also being developed for people who do not have the option of other types of transplants.
- Conditions
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia
- Being tested
- Expansion of umbilical cord stem cells
- Keywords
- umbilical cord blood, transplant, ALL, AML, MDS, NHL, CML
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Lymphoma, Non-Hodgkin, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expansion of umbilical cord stem cellsProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2004 (estimated)
- Study startMar 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- ViaCell
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kurt Gunter, MD, Study director, ViaCell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089596
- Sponsor's protocol ID
- CB001
- Status last verified
- Apr 2007
- First submitted
- 6 Aug 2004
- Last updated
- 12 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of Infusion of Ex Vivo Selectively Amplified Unrelated Cord Blood Stem Cells in Subjects With Hematological Malignancies Receiving Unrelated Cord Blood Transplantation
- ClinicalTrials.gov ID
- NCT00089596
- Acronym / sponsor ID
- CB001
- Conditions
- Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma, Chronic Myelogenous Leukemia
- Keywords
- umbilical cord blood, transplant, ALL, AML, MDS, NHL, CML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- ViaCellIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Oct 2006
- First posted
- 10 Aug 2004 (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.
This study hopes to show that specially treated umbilical cord cells, called stem cells, can be safely given to a person after they receive chemoradiation therapy or chemotherapy for their illness. During chemoradiation therapy or chemotherapy, a person loses all of the cells that are needed to make the different types of cells in their blood, including their immune system cells. These cells must be replaced in order for the blood and immune systems to work properly. Some people receive bone marrow transplants or other types of stem cell transplants to get the cells they need. CB001 is being developed as an option for people who need bone marrow transplants or other types of transplants to replace those cells. It is also being developed for people who do not have the option of other types of transplants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Do not have identical or 5/6 related matched bone marrow, peripheral blood or umbilical cord
- Stable disease and lack of unrelated donor
- Acute myeloid leukemia (AML) in 2nd or subsequent complete remission or first remission with high risk features
- ALL in 2nd or subsequent remission or first remission with high risk features
- Myelodysplastic syndrome (MDS)
Key exclusion criteria (11 listed)
- Females who are pregnant
- Poor ability to perform daily activities
- Weight under 40 kilograms (88 pounds)
- AML caused by chemoradiation
- Prior stem cell transplant
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 |
|---|---|---|
| Expansion of umbilical cord stem cells | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 12 Apr 2007.
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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.
Kurt Gunter, MD study director
ViaCell
4 sites 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 Expansion of umbilical cord stem cells in people with Acute Lymphocytic Leukemia and Acute Myeloid Leukemia, run by ViaCell at 4 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 8 inclusion and 11 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 12 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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 12 Apr 2007.