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| Name | Class |
|---|---|
| Rambam Health Care Campus | OTHER |
| Laniado Hospital | OTHER |
| Meir Medical Center | OTHER |
| Rabin Medical Center |
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Recently, a novel assay for detecting heavy/light chain (HLC) ratios has been reported which enables improvement in paraprotein detection and monitoring in multiple myeloma and other plasma-cell dyscrasias.
The prognostic and biological role of the HLC assay has as yet not been studied in CLL.
Aims of the proposed study:
Analysis of immunoglobulin heavy/light chain pairs In chronic lymphocytic leukemia
Introduction and Background:
Chronic Lymphocytic Leukemia (CLL) is the most common type of leukemia in the western world. Median age at diagnosis is 72 years, and the male to female ratio is 2:1. The disease is characterized by an accumulation of monoclonal mature B-cells which co-express the T-cell antigen CD5, B-cell surface antigens CD19, CD20, and CD23(1) and either kappa or lambda immunoglobulin light chains restriction (2). Diagnosis is established based on the IWCLL criteria published by Hallek at al in 2008. (1).
CLL may have a heterogeneous clinical course with a wide spectrum of manifestations ranging from long lived asymptomatic patients who never require treatment to those with a more rapid clinical course and symptomatic progression. One of the remaining important challenges in CLL is to stratify patients into different prognostic categories, so as to plan appropriate targeted therapy when necessary . The most important prognostic factor in CLL relates to the presence of typical genomic aberrations in the leukemic cell (3). Other essential prognostic parameters include: CD38 expression, the presence of ZAP-70, immunoglobulin heavy chain mutational status, and beta 2 microglobulin (B2MG) levels. (1).
Patients with CLL, have a 10 % risk of developing autoimmune complications mostly auto-immune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP) (4-6). The pathogenesis for these autoimmune cytopenias is linked to the production of polyclonal immunoglobulin G (IgG) antibodies (less frequently IgM) directed against a variety of red blood cell or platelet antigens. (4-6).
The use of serum free light chain (FLC) levels as an important prognostic tool in different plasma cell dyscrasias is already well established (75) while the prognostic significance of FLC in CLL has only been reported more recently by few publications (8-10). Furthermore, Tsai et al, have also described that serum FLC abnormalities may precede diagnosis in 38 % of patients with CLL (11).
Recently, a novel assay for detecting heavy/light chain (HLC) ratios has been reported which enables improvement in paraprotein detection and monitoring in multiple myeloma and other plasma-cell dyscrasias. (12-13).
The prognostic and biological role of the HLC assay has as yet not been studied in CLL.
Aims of the proposed study:
Materials and methods:
The study will be performed in collaboration with the Israeli CLL Study Group.
All patients included will have complete clinical database available and medical records summarized.
Baseline laboratory parameters to be examined will include: complete blood count, Coombs test, serum B2MG and LDH, Immunoglobulin levels,, flow-cytometry including CD38 expression and ZAP70 and urine Bence Jones protein.
Frozen serum samples from CLL patients will be analyzed for levels of:
References:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervantion | Other |
| Measure | Description | Time Frame |
|---|---|---|
| 1) To quantify and analyze the prognostic significance of HLC ratios in the serum of CLL patients. (In addition to FLC) | 5 years |
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Inclusion Criteria:
New diagnosed patients with CLL (untreated)
Exclusion Criteria:
Not treated with immunoglobulin Not treated with steroids
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Age>18 years Patients diagnosed with CLL
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center | Recruiting | Haifa | Israel | 31048 | Israel |
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| OTHER |
| Kaplan Medical Center | OTHER |
| Shaare Zedek Medical Center | OTHER |
| Hadassah Medical Organization | OTHER |
| HaEmek Medical Center, Israel | OTHER |
| Western Galilee Hospital-Nahariya | OTHER_GOV |
| Tel-Aviv Sourasky Medical Center | OTHER_GOV |
| Assaf-Harofeh Medical Center | OTHER_GOV |
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Serum