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Protocol Details

Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Chronic Lymphocytic Leukemia (CLL);
Monoclonal B Cell Lymphocytosis;
Small Lymphocytic Lymphoma (SLL);
Natural History

Recruitment Keyword(s)



Waldenstrom Macroglobulinemia;
Lymphoplasmacytic Lymphoma;
Monoclonal B-Cell Lymphocytosis;
Small Lymphocytic Lymphoma;
CLL (Chronic Lymphocytic Leukemia)

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Heart, Lung, and Blood Institute


The development of new technologies now allow scientists to investigate the molecular basis and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia(CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in a natural history study can clarify processes involved in disease progression and possibly lead to the discovery or validation of treatment targets.


--Study the history of MBL/CLL/SLL/LPL/WM/SMZL in patients prior to and after treatment.

--Characterize clinical, biologic and molecular events of disease stability and progression of patients enrolled on this protocol.


--Diagnosis of MBL/CLL/SLL/LPL/WM/SMZL

--Age greater than or equal to 18 years.

--Patients with CLL/SLL in remission after chemotherapy are excluded.

--ECOG performance status of 0-2.


--Patients are typically followed every 6 to 24 months in the clinic and have blood drawn. When required patients may undergo additional testing that may include bone marrow biopsy and aspiration, blood drawing, lymph node biopsy, x-ray studies, positron emission tomography and CT and MRI scans. Some of these tests may be required to monitor CLL/SLL, LPL/WM, and SMZL patients. Other tests, such as bone marrow biopsy and aspiration, lymph node biopsy, may not be clinically indicated, but patients may be asked to undergo these procedures for research purposes.

--No treatment will be administered on this study. If a patients requires treatment for their cancer, available NIH clinical trials and alternative treatment options will be discussed with the patient.

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1. Diagnosis of CLL/SLL will be made according to the updated criteria of the NCI Working Group. OR Diagnosis of MBL according to the updated criteria of the NCI Working Group and the absence of pathologic lymphadenopathy or autoimmune disease. OR Diagnosis of LPL/WM according to the consensus panel criteria from the International Workshop on Waldenstrom's Macroglobulinemia. OR

Diagnosis of SMZL as outlined by Matutes, et al.

2. Age greater than or equal to 18 years.

3. ECOG performance status of 0-2.

4. Able to comprehend the investigational nature of the protocol and provide informed consent


1. Patients with CLL/SLL in remission following previous chemotherapy

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Clare C. Sun, M.D.
National Heart, Lung and Blood Institute (NHLBI)

Susan Soto, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 4-5362
10 Center Drive
Bethesda, Maryland 20892
(301) 402-0797

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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