B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01028430
First received: December 8, 2009
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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
Chronic Lymphocytic Leukemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: B Cell Repertoires in Chronic Lymphocytic Leukemia and Aging

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Description:

Blood cells, tissue


Estimated Enrollment: 1000
Study Start Date: July 1998
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028430

Locations
United States, New York
Feinstein Institute for Medical Research
Manhasset, New York, United States, 11030
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Nicholas Chiorazzi, MD North Shore-LIJ Health System
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01028430     History of Changes
Other Study ID Numbers: 04-046
Study First Received: December 8, 2009
Last Updated: February 5, 2013
Health Authority: United States: Federal Government

Keywords provided by North Shore Long Island Jewish Health System:
Chronic Lymphocytic Leukemia

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

ClinicalTrials.gov processed this record on October 19, 2014