B-type Chronic Lymphocytic Leukemia (B-CLL) Subgroups: Maturation Stage and Gene Expression

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01030913
First received: December 10, 2009
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

B type chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the western world. It is a disease that occurs primarily in aging individuals and occurs more frequently in males than females. Although B-CLL was considered a homogeneous condition, recent studies by our laboratory and others suggest that B-CLL cases can be divided into two subgroups.

These sub-groups can be identified by either the presence or the absence of mutations in antibody genes and/or by the percentage of B-CLL cells expressing a particular protein called CD38. These two sub-groups (unmutated antibody genes high percent CD38 and mutated antibody genes low percentage CD38) follow strikingly clinically different courses. For example, the unmutated/CD38+ group experiences a much more aggressive disease and these patients almost invariably die much sooner than the cases in the other group. In addition, the patients in the mutated CD38+ group require much more chemotherapy than mutatedlCD38-. Finally, surprisingly there is a much higher representation of males in the poor outcome unmutated CD38 group than in the better outcome group. The reasons for these differences in clinical outcome and gender bias are unknown.


Condition
Chronic Lymphocytic Leukemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: B-CLL Subgroups: Maturation Stage and Gene Expression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • differentiating B-CLL cells by the presence or absence of mutations in antibody genes and/or by the percentage of cells expressing CD38 and the differnce in clinical disease course and outcome for each group [ Time Frame: follow through the clinical disease course for each group ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood Cells, Bone Marrow


Estimated Enrollment: 1248
Study Start Date: December 1999
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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 able to contribute the required amount of blood without compromising their well being,
  • Participants must be willing to be contacted again in the future for additional blood drawing.

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: NCT01030913

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: NCT01030913     History of Changes
Other Study ID Numbers: 04-057
Study First Received: December 10, 2009
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014