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Direct Measurement of Leukemic Cell Turnover (Synthesis and Removal) in Patients With Chronic Lymphocytic Leukemia Using Deuterated Water (GAC 0004)

18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia

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Trial Information

Direct Measurement of Leukemic Cell Turnover (Synthesis and Removal) in Patients With Chronic Lymphocytic Leukemia Using Deuterated Water (GAC 0004)

Chronic lymphocytic leukemia. B-cell chronic lymphocytic leukemia (B-CLL) is the most
prevalent leukemia in the Western Hemisphere, accounting for ~25% of all leukemia's. It
represents a monoclonal expansion of small, long-lived, apparently slowly dividing CD5+ B
cells. Because of the low proliferative index and a presumed uniform proliferative rate of
B-CLL cells in vivo (a fact not yet tested or documented), B-CLL appears to be primarily a
disease of accumulation rather than proliferation.

B-CLL remains an incurable illness and there is no survival benefit to early intervention.

Therefore, patients with early stage disease are usually followed closely without initiating
treatment. Patients with more extensive disease or progressive cytopenias are eventually
treated with cytotoxic agents, with or without prednisone, or with nucleoside analogues that
promote apoptosis in the leukemic cells. The clinical outcome of the disease is determined
both by the profound dysregulation of the immune system that results in infection and
autoimmunity and by leukemic infiltration and destruction of organs. Autoimmune phenomena
are common and frequently directed against hematopoietic cells, resulting in autoimmune
hemolytic anemia (10-25%) or immune thrombocytopenia.

Inclusion Criteria:

- Must be 18 years of age.

- Must meet the clinical and laboratory criteria for B-CLL (i.e., compatible clinical
history and physical exam, presence of lymphocytosis, i.e., >10,000 lymphocytes /
mm3, evidence for a monoclonal population of CD5+/CD19+/CD23+ cells in the periphery
that have dim surface membrane lg with L chain isotype restriction).

- All patients will be staged according to the system of Rai. Only new onset patients
who are not receiving therapy will be entered into the heavy water leukemic cell
turnover studies.

Exclusion Criteria:

- Patients hospitalized for an acute medical problem, related or not to their leukemia,
within 4 weeks of enrollment.

- A history of a second malignancy involving the hematopoietic system, or the need for
extensive chemotherapy for any second malignancy; patients with active immunologic
disorders (e.g., HIV and AIDS), especially autoimmune problems (e.g., autoimmune
hemolytic anemia of any cause other than B-CLL).

- Patients with impaired decision-making capabilities, e.g. dementia, psychosis,
alcoholism, and illicit drug use will also be excluded.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

B Cell Chronic Lymphocytic Leukemia Subgroups: Direct measurement of leukemic cell turnover (synthesis and removal) using deuterated water as a DNA-labeling agent in patients with chronic lymphocytic leukemia

Outcome Description:

We believe that the results of these studies may identify in vivo correlates of the in vitro studies we have performed previously. Kinetic analyses may be another way to identify patients with different levels of risk from this disease and thereby provide an additional prognostic parameter. This information may also help to individualize future therapies for specific patients based on the in vivo biology in their particular B-CLL clone.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Nicholas Chiorazzi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Feinstein Institute for Medical Research


United States: Institutional Review Board

Study ID:




Start Date:

June 2001

Completion Date:

January 2015

Related Keywords:

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



Feinstein Institute for Medical Research Manhassett, New York  11030