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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Northwell Health
Sponsor:
Information provided by (Responsible Party):
Nicholas Chiorazzi, Northwell Health
ClinicalTrials.gov Identifier:
NCT01030913
First received: December 10, 2009
Last updated: April 13, 2016
Last verified: April 2016
  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 Northwell Health:

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 difference 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 2019
Estimated Primary Completion Date: January 2019 (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   (Adult, Senior)
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

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
  More Information

Responsible Party: Nicholas Chiorazzi, Investigator, The Feinstein Institute for Medical Research, Northwell Health
ClinicalTrials.gov Identifier: NCT01030913     History of Changes
Other Study ID Numbers: 04-057 
Study First Received: December 10, 2009
Last Updated: April 13, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 28, 2016