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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01460238
Other study ID # D11065
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2011
Est. completion date May 2018

Study information

Verified date March 2019
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year
Secondary 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 1 year
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