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Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects


N/A
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects


By ingesting a non-radioactive and non-toxic compound "heavy water" for 6 weeks, the DNA of
newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia
(B-CLL) can be labeled and followed by performing routine blood draws at specified time
intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells
are generated in the bone marrow and how quickly they leave the blood, a measure of cell
turnover. This will help us to better understand the unique characteristics of this disease
process.


Inclusion Criteria:



- 18 years of age,

- Patients must be willing to contribute the required amount of blood without
compromising their well being,

- Participants must be willing to be contacted in the future.

Exclusion Criteria:

- Pregnancy,

- Patients who are known to be anemic, with a hemoglobin < 8,

- Patients who are known to be infected with HIV.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects

Outcome Description:

B-CLL is a dx of accumulation rather than proliferation. Evidence for various forms of clonal evolution suggests that B-CLL clones may be more dynamic than previously assumed. A non-radioactive, stable isotopic labeling method to measure B-CLL cell kinetics in vivo. Subjects drank an aliquot of 2H2O daily for 84 days, and 2H incorporation into the deoxyribose moiety of DNA of their newly divided B-CLL cells, measured by gc/ms, during the labeling period. Birth rates were calculated from the kinetic profiles. Death rates were defined as the difference between calculated birth and growth rates.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Nicholas Chiorazzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Feinstein Institute for Medical Research

Authority:

United States: Institutional Review Board

Study ID:

05-05-096

NCT ID:

NCT01110863

Start Date:

December 2005

Completion Date:

January 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location
Feinstein Institute for Medical Research Manhassett, New York  11030