Protocol Number: 08-C-0105

Title:

Natural History Study of Monoclonal B Cell Lymphocytosis (MBL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Number:

08-C-0105

Summary:

Background:

-The development of new technologies now allow scientists to investigate the genetic basis of monoclonal B cell lymphocytosis (MBL) and chronic lymphocytic leukemia(CLL)/Small lymphocytic lymphoma (SLL) and their clinical manifestations. Applying these methods in a natural history study can clarify processes involved in disease progression and possibly lead to the discovery or validation of treatments.

Objectives:

-To describe the natural course of MBL and CLL/SLL in patients before they need treatment.

-To characterize in each patient the clinical, biologic and molecular events of disease stability and progression.

Eligibility:

-Patients 18 years of age or older diagnosed with either MBL or CLL/SLL.

Design:

-Patients are followed every 3 to 12 months with tests that may include bone marrow biopsy and aspiration, blood drawing, lymph node biopsy, x-ray studies, positron emission tomography and CT scans of the neck, chest, abdomen, and pelvis. Because these tests are routinely done to monitor MBL and CLL/SLL, participants need not undergo additional tests specifically for research. (Bone marrow biopsy and aspiration and lymph node biopsy are often not required to diagnose CLL/SLL, but patients may be asked to undergo these procedures for research purposes in this study.)

-Clinical information is collected and stored in a central databank.

-Patients whose cancer requires treatment will be taken off the study and treatment options will be discussed with them. If no NIH treatment protocols are available to them, they will be returned to the care of their local physician.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

1. Diagnosis of CLL/SLL will be made according to the NCI Working Group and the WHO diagnostic classification and will be confirmed in the NCI Laboratory of Pathology. Patients with familial CLL may be included. A lymphocyte count in excess of 5000 per microl is typically found in the leukemic variant but is not required for a diagnosis of SLL. Presence of a light chain restricted clonal B cell population in the context of an ALC of less than 5,000 cells per microl is defined as MBL. In addition there is to be no history of autoimmune disease and no evidence of lymphadenopathy on physical exam.

2. Age greater than or equal to 18 years.

3. ECOG performance status of 0-2.

4. The patient must be competent to sign an informed consent, and sign the protocol consent form.

EXCLUSION CRITERIA:

1. Any patient with a medical condition that requires chronic use of corticosteroids.

2. Patients who have received previous cytotoxic or monoclonal antibody therapy for CLL/SLL.

Special Instructions:

Currently Not Provided

Keywords:

Gene Expression

Prognosis

Watch and Wait

Molecular Genetics

Biologic Markers

Recruitment Keyword(s):

Leukemia

Lymphoma

Condition(s):

B-cell Chronic Lymphocytic Leukemia

Monoclonal B-Cell Lymphocytosis

Lymhoma, Small Lymphocytic

Chronic Lymphocytic Leukemia

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Rai KR, Sawitsky A, Cronkite EP, Chanana AD, Levy RN, Pasternack BS. Clinical staging of chronic lymphocytic leukemia. Blood. 1975 Aug;46(2):219-34.

Marti GE, Rawstron AC, Ghia P, Hillmen P, Houlston RS, Kay N, Schleinitz TA, Caporaso N; The International Familial CLL Consortium. Diagnostic criteria for monoclonal B-cell lymphocytosis. Br J Haematol. 2005 Aug;130(3):325-32. Review.

Shim YK, Vogt RF, Middleton D, Abbasi F, Slade B, Lee KY, Marti GE. Prevalence and natural history of monoclonal and olyclonal B-cell lymphocytosis in a residential adult population. Cytometry B Clin Cytom. 2007 Sep;72(5):344-53.

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