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Lipoprotein Lipase Expression in Chronic Lymphocytic Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01460238
First Posted: October 26, 2011
Last Update Posted: May 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
  Purpose
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.

Condition
Chronic Lymphocytic Leukemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lipoprotein Lipase Expression in Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Fatty acid acquisition and synthesis [ Time Frame: 1 year ]
    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


Biospecimen Retention:   Samples With DNA
10 cc of peripheral blood and Archived lymph node tissue or bone marrow samples

Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
No intervention. Each patient will have blood drawn at a standard of care venipuncture.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center with CLL
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460238


Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
American Cancer Society, Inc.
Investigators
Principal Investigator: Frederick Lansigan, MD Dartmouth-Hitchcock Medical Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460238     History of Changes
Other Study ID Numbers: D11065
First Submitted: October 24, 2011
First Posted: October 26, 2011
Last Update Posted: May 5, 2016
Last Verified: May 2016

Keywords provided by Dartmouth-Hitchcock Medical Center:
Lipoprotein Lipase
Chronic Lymphocytic Leukemia
CLL

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell