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

NCT ID: NCT01030913

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1248 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-12-31
• Study Completion Date: 2023-09-30

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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Chiorazzi, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Feinstein Institute for Medical research

Manhasset, New York, United States

Countries

United States

Other Identifiers

04-057

Identifier Type: -

Identifier Source: org_study_id