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

NCT01030913 | Completed

• 1 other identifier: 04-057
• Study Type: observational
• Target: 1,248
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (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

  follow through the clinical disease course for each group

Study Arms (1)

Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chronic Lymphocytic Leukemia Community Sample

You may qualify if:

• 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.

You may not qualify if:

• Patients who are known to be anemic, with a hemoglobin \< 8,
• Patients who are known to be infected with HIV.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Feinstein Institute for Medical research

Manhasset, New York, 11030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Cells, Bone Marrow

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Chiorazzi, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: December 1, 1999
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

US (1)