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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01030913
Recruitment Status : Recruiting
First Posted : December 14, 2009
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):
Nicholas Chiorazzi, Northwell Health

Brief Summary:

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 or disease
Chronic Lymphocytic Leukemia

Study Type : Observational
Estimated Enrollment : 1248 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: B-CLL Subgroups: Maturation Stage and Gene Expression
Study Start Date : December 1999
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia

Primary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Blood Cells, Bone Marrow

Information from the National Library of Medicine

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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

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.

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 identifier (NCT number): NCT01030913

Contact: Yasmine Kieso, MSCR

United States, New York
Feinstein Institute for Medical research Recruiting
Manhasset, New York, United States, 11030
Contact: Yasmine Kieso, MSCR   
Principal Investigator: Nicholas Chiorazzi, M.D         
Sponsors and Collaborators
Northwell Health
Principal Investigator: Nicholas Chiorazzi, MD Northwell Health

Responsible Party: Nicholas Chiorazzi, Investigator, The Feinstein Institute for Medical Research, Northwell Health Identifier: NCT01030913     History of Changes
Other Study ID Numbers: 04-057
First Posted: December 14, 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, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell