Chronic Lymphocytic LeukemiaNCT01460238
Lipoprotein Lipase Expression in Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic Lymphocytic Leukemia (CLL) cells will predict a more aggressive clinical course. The results from this proposal will validate the use of a novel antibody developed at Dartmouth-Hitchcock in CLL and will predict CLL patients that have a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to May 2018
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center with CLL
Who may be able to join
- Diagnosis of CLL as per National Cancer Institute Working Group Guidelines
- Patients undergoing routine blood draws as part of their ongoing follow up for CLL
- 18 years or older
- Ability to provide consent in English
- Patient must have measurable disease as defined by an absolute lymphocyte count greater than 5,000/mm3 or have archived lymph node or bone marrow with CLL involvement.
Who cannot join
- Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their CLL,
- other hematologic malignancy or other disease process within the past 6 months are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic Lymphocytic Leukemia (CLL) cells will predict a more aggressive clinical course. The results from this proposal will validate the use of a novel antibody developed at Dartmouth-Hitchcock in CLL and will predict CLL patients that have a more aggressive form of the disease. The investigators work will also provide direct evidence that LPL is expressed on CLL cells and provides a critical source of fatty acids required by the CLL cells to grow and survive. Fatty acid metabolism may become a therapeutic target in CLL in the future.
Read the detailed description
The investigators plan to use a novel antibody developed at Dartmouth-Hitchcock Medical Center to characterize the expression of LPL in CLL. Peripheral blood from CLL patients will be analyzed by flow cytometry to detect the expression of LPL and to investigate if LPL expression correlates with a more aggressive type of CLL. The investigators propose that LPL protein expression on CLL cells is prognostic and that LPL and other proteins involved in fatty acid metabolism are critical for CLL cells to survive.
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Lipoprotein Lipase, Chronic Lymphocytic Leukemia, CLL
- 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 |
|---|---|---|
| No treatment | No intervention. Each patient will have blood drawn at a standard of care venipuncture. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPL Protein Expression
Determine the degree of LPL protein expression in CLL cells using a novel LPL antibody, correlate with IgHV mutation status, and compare this association with other prognostic markers
Measured: 1 year
Secondary outcomes (1)
Fatty acid acquisition and synthesis
Demonstrate that CLL cells also possess the enzymatic machinery for fatty acid acquisition and synthesis as shown by the expression of LPL, CD36, SDC1, and fatty acid synthase
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 posted26 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2018
- Study completionMay 2018
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 Dartmouth-Hitchcock Medical CenterThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Frederick Lansigan, Dartmouth-Hitchcock Medical Center
- Investigators
- Frederick Lansigan, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460238
- Sponsor's protocol ID
- D11065
- Status last verified
- Mar 2019
- First submitted
- 24 Oct 2011
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipoprotein Lipase Expression in Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT01460238
- Acronym / sponsor ID
- D11065
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- Lipoprotein Lipase, Chronic Lymphocytic Leukemia, CLL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Oct 2011
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 26 Oct 2011 (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 investigators hypothesize that Lipoprotein Lipase (LPL) expression on Chronic Lymphocytic Leukemia (CLL) cells will predict a more aggressive clinical course. The results from this proposal will validate the use of a novel antibody developed at Dartmouth-Hitchcock in CLL and will predict CLL patients that have a more aggressive form of the disease. The investigators work will also provide direct evidence that LPL is expressed on CLL cells and provides a critical source of fatty acids required by the CLL cells to grow and survive. Fatty acid metabolism may become a therapeutic target in CLL in the future.
Detailed description
The investigators plan to use a novel antibody developed at Dartmouth-Hitchcock Medical Center to characterize the expression of LPL in CLL. Peripheral blood from CLL patients will be analyzed by flow cytometry to detect the expression of LPL and to investigate if LPL expression correlates with a more aggressive type of CLL. The investigators propose that LPL protein expression on CLL cells is prognostic and that LPL and other proteins involved in fatty acid metabolism are critical for CLL cells to survive.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –No intervention. Each patient will have blood drawn at a standard of care venipuncture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center with CLL
Key inclusion criteria (5 listed)
- Diagnosis of CLL as per National Cancer Institute Working Group Guidelines
- Patients undergoing routine blood draws as part of their ongoing follow up for CLL
- 18 years or older
- Ability to provide consent in English
- Patient must have measurable disease as defined by an absolute lymphocyte count greater than 5,000/mm3 or have archived lymph node or bone marrow with CLL involvement.
Key exclusion criteria (2 listed)
- Patients who have received cytotoxic drug, oral or intravenous steroid or targeted antibody therapy for their CLL,
- other hematologic malignancy or other disease process within the past 6 months are excluded.
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
LPL Protein Expression
Time frame: 1 year
Determine the degree of LPL protein expression in CLL cells using a novel LPL antibody, correlate with IgHV mutation status, and compare this association with other prognostic markers
1 secondary outcome
Fatty acid acquisition and synthesis
Time frame: 1 year
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 28 Mar 2019.
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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.
Frederick Lansigan, MD principal investigator
Dartmouth-Hitchcock Medical Center
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 Dartmouth-Hitchcock Medical 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 5 inclusion and 2 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 28 Mar 2019. 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?
LPL Protein Expression (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 28 Mar 2019.