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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110863
• Other study ID #: 05-05-096
• Secondary ID: GAC # 0117
• Status: Completed
• Start date: December 2005
• Est. completion date: February 12, 2016

Study information

• Verified date: March 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 12, 2016
• Est. primary completion date: February 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Feinstein Institute for Medical Research	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects	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.	1 year