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B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging

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ClinicalTrials.gov Identifier: NCT01028430
Recruitment Status : Recruiting
First Posted : December 9, 2009
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
Nicholas Chiorazzi, Northwell Health

Brief Summary:
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.

Condition or disease
Chronic Lymphocytic Leukemia

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging
Study Start Date : July 1998
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


Group/Cohort
Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia



Primary Outcome Measures :
  1. 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. ]

Biospecimen Description:
Blood cells, tissue


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Chronic Lymphocytic Leukemia Community Sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028430


Contacts
Contact: Yasmine Kieso, MSCR ykieso@nshs.edu

Locations
United States, New York
Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact: Yasmine Kieso, MSCR       ykieso@nshs.edu   
Principal Investigator: Nicholas Chiorazzi, M.D.         
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Nicholas Chiorazzi, MD Northwell Health

Responsible Party: Nicholas Chiorazzi, Investigator, The Feinstein Institute for Medical Research, Northwell Health
ClinicalTrials.gov Identifier: NCT01028430     History of Changes
Other Study ID Numbers: 04-046
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Keywords provided by Nicholas Chiorazzi, Northwell Health:
Chronic Lymphocytic Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell