NCT01460238

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

6.6 years

First QC Date

October 24, 2011

Last Update Submit

March 27, 2019

Conditions

Keywords

Lipoprotein LipaseChronic Lymphocytic LeukemiaCLL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Fatty acid acquisition and synthesis

    1 year

Study Arms (1)

No treatment

No intervention. Each patient will have blood drawn at a standard of care venipuncture.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at Dartmouth-Hitchcock Medical Center's Norris Cotton Cancer Center with CLL

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

10 cc of peripheral blood and Archived lymph node tissue or bone marrow samples

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frederick Lansigan, MD

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 24, 2011

First Posted

October 26, 2011

Study Start

October 1, 2011

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

March 28, 2019

Record last verified: 2019-03

Locations