Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Sponsor North Shore Long Island Jewish Health System
Start date June 2001
End date January 2016
Trial size 50 participants
Trial identifier NCT01110850, 01-054, GAC # 0004

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Chronic Lymphocytic Leukemia

Primary Outcomes

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
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Direct Measurement of Leukemic Cell Turnover (Synthesis and Removal) in Patients With Chronic Lymphocytic Leukemia Using Deuterated Water (GAC 0004)
Principal investigator Nicholas Chiorazzi, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by North Shore Long Island Jewish Health System.