- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01028430
B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging
March 25, 2024 updated by: Northwell Health
B-CLL is the most prevalent leukemia in the Western hemisphere, accounting for ~25% of all leukemia's (1).
This disease occurs virtually exclusively in the aging population, with the median age of diagnosis ranging between the mid 60s and the early 70s.
Indeed, its occurrence before the age of 50 is quite unusual.
This increase in occurrence with age is not unique to B-CLL; rather, it is characteristic several B cell lymphoproliferative disorders (e.g., non-Hodgkin's lymphoma, multiple myeloma).
Gender and race also influence the development of B-CLL.
Thus, the ratio of men: women is ~2:1 and the prevalence is increased in Caucasians.
The rate of occurrence of B-CLL among Asians is significantly lower than for Caucasians and this does not increase with immigration to the West.
DNA sequence analyses performed in our laboratory and in those of others indicate that B-CLL cells from unrelated patients share Ig V gene characteristics.
These include the use of selected genes, the association of these genes with certain D and JH gene segments that code for unique CDR3 motifs, and the occasional occurrence of highly similar VHDJH + VLJL pairs.
In ~50% cases, these rearranged genes are mutated, whereas in the others mutations are infrequent; this difference is related to the VH gene family used by the B-CLL cell.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Manhasset, New York, United States, 11030
- Feinstein Institute for Medical research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Chronic Lymphocytic Leukemia Community Sample
Description
Inclusion Criteria:
- 18 years of age Patients must be willing to be contacted in the future
Exclusion Criteria:
- Patients who are known to be anemic, with a hemoglobin <8 PAtients who are known to be infected with HIV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Chronic Lymphocytic Leukemia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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expression of cell surface antigens HLA-DR and CD38+ markers in B-CLL cells compared to normal B-lymphocytes
Time Frame: samples will be taken at the beginning, week 2, 4,6,8,12,and 24 (for blood), and bone marrow samples at weeks 2 and 6.
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samples will be taken at the beginning, week 2, 4,6,8,12,and 24 (for blood), and bone marrow samples at weeks 2 and 6.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nicholas Chiorazzi, MD, Northwell Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1998
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
December 8, 2009
First Submitted That Met QC Criteria
December 8, 2009
First Posted (Estimated)
December 9, 2009
Study Record Updates
Last Update Posted (Estimated)
March 27, 2024
Last Update Submitted That Met QC Criteria
March 25, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Hematologic Diseases
- Leukemia, B-Cell
- Chronic Disease
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Other Study ID Numbers
- 04-046
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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