Lipoprotein Lipase Expression in Chronic Lymphocytic Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01460238
First received: October 24, 2011
Last updated: April 29, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460238

Contacts
Contact: Frederick Lansigan, MD 800-639-6918 Cancer.Research.Nurse@Dartmouth.edu

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Frederick Lansigan, MD    800-639-6918    Cancer.Research.Nurse@Dartmouth.edu   
Principal Investigator: Frederick Lansigan, MD         
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
American Cancer Society, Inc.
Investigators
Principal Investigator: Frederick Lansigan, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01460238     History of Changes
Other Study ID Numbers: D11065
Study First Received: October 24, 2011
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014