Chronic Lymphocytic LeukemiaNCT01110863
Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects
An observational study of Chronic Lymphocytic Leukemia, run by Northwell Health at 1 site in United States.
Trial summary
By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be labeled and followed by performing routine blood draws at specified time intervals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to 12 Feb 2016
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic Lymphocytic Luekemia
Who may be able to join
- 18 years of age,
- Patients must be willing to contribute the required amount of blood without compromising their well being,
- Participants must be willing to be contacted in the future.
Who cannot join
- Pregnancy,
- Patients who are known to be anemic, with a hemoglobin < 8,
- Patients who are known to be infected with HIV.
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.
Read the detailed description
By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia (B-CLL) can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects
B-CLL is a dx of accumulation rather than proliferation. Evidence for various forms of clonal evolution suggests that B-CLL clones may be more dynamic than previously assumed. A non-radioactive, stable isotopic labeling method to measure B-CLL cell kinetics in vivo. Subjects drank an aliquot of 2H2O daily for 84 days, and 2H incorporation into the deoxyribose moiety of DNA of their newly divided B-CLL cells, measured by gc/ms, during the labeling period. Birth rates were calculated from the kinetic profiles. Death rates were defined as the difference between calculated birth and growth rates.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startDec 2005
- Primary completion12 Feb 2016
- Study completion12 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Chiorazzi, Northwell Health
- Investigators
- Nicholas Chiorazzi, MD, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110863
- Sponsor's protocol ID
- 05-05-096
- Other IDs
- GAC # 0117
- Status last verified
- Mar 2021
- First submitted
- 10 Dec 2009
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects
- ClinicalTrials.gov ID
- NCT01110863
- Acronym / sponsor ID
- 05-05-096
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- 12 Feb 2016 (actual)
- Study completion
- 12 Feb 2016 (actual)
- First posted
- 27 Apr 2010 (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.
By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.
Detailed description
By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia (B-CLL) can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Lymphocytic Leukemia | – | –Chronic Lymphocytic Leukemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Lymphocytic Luekemia
Key inclusion criteria (3 listed)
- 18 years of age,
- Patients must be willing to contribute the required amount of blood without compromising their well being,
- Participants must be willing to be contacted in the future.
Key exclusion criteria (3 listed)
- Pregnancy,
- Patients who are known to be anemic, with a hemoglobin < 8,
- Patients who are known to be infected with HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects
Time frame: 1 year
B-CLL is a dx of accumulation rather than proliferation. Evidence for various forms of clonal evolution suggests that B-CLL clones may be more dynamic than previously assumed. A non-radioactive, stable isotopic labeling method to measure B-CLL cell kinetics in vivo. Subjects drank an aliquot of 2H2O daily for 84 days, and 2H incorporation into the deoxyribose moiety of DNA of their newly divided B-CLL cells, measured by gc/ms, during the labeling period. Birth rates were calculated from the kinetic profiles. Death rates were defined as the difference between calculated birth and growth rates.
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 Mar 2021.
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Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
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.
Nicholas Chiorazzi, MD principal investigator
Feinstein Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Northwell Health 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 3 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 Mar 2021. 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.
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?
Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects (time frame: 1 year). 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 3 Mar 2021.