Natural History Study of Monoclonal B Cell Lymphocytosis and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Identifier:
First received: June 17, 2009
Last updated: August 27, 2015
Last verified: September 2014


-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.


  • 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.


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


  • 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.

B-Cell Chronic Lymphocytic Leukemia
Monoclonal B-Cell Lymphocytosis
Lymhoma, Small Lymphocytic
Chronic Lymphocytic Leukemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Natural History Study of Monoclonal B Cell Lymphocytosis(MBL) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma(CLL/SLL), Lmphoplasmacytic Lymphoma(LPL)Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma(SMZL)

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: April 2008
Detailed Description:

The purpose of this protocol is to collect blood, tissue (bone marrow and lymph node biopsies) and/or imaging studies (PET and CT scans) from patients with monoclonal B cell lymphocytosis (MBL) chronic lymphocytic leukemia/small lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstr(SqrRoot)(Delta)m macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL).

Assessments will be used for clinical and translational research investigating the molecular basis of MBL, CLL/SLL, LPL/WM, SMZL and their clinical manifestations. New technologies now permit the simultaneous characterization of pathogenic events ranging from the control of gene expression to the characterization of the molecular events of cell-cell interactions. Applying these methods to MBL/CLL/SLL/LPL/WM/SMZL in the context of a natural history protocol can help unravel cellular pathways involved in pathogenesis and disease progression and lead to the discovery or the validation of therapeutic targets. MBL/CLL/SLL/LPL/WM/SMZL is an incurable disease for which there are no reliable cell lines and only a few mouse models. There is an urgent need to obtain a flow of primary samples to advance research into pathogenesis and novel treatment approaches.


  • Diagnosis of MBL/CLL/SLL/LPL/WM/SMZL
  • Age greater than or equal to 18 years.
  • Patients must have received no previous cytotoxic, monoclonal antibody, or kinase inhibitor therapy for CLL/SLL/LPL/WM/SMZL.
  • ECOG performance status of 0-2.


-Patients will be typically followed every 6-12 months for the first 2 years and every 12-24 months thereafter. Interim visits may occur at the discretion of the research team. Patients may donate cellular products or tissues as appropriate for research purposes. Clinical information will be obtained and stored in a central databank.


  • Describe the natural history of MBL/CLL/SLL/LPL/WM/SMZL in patients prior to the time when their disease requires treatment.
  • Apply the expertise and available technologies of the investigators to advance our understanding of disease pathogenesis and develop novel treatment approaches for CLL/SLL/LPL/WM/SMZL.
  • Provide evaluation, diagnostic studies and monitoring for patients on study.
  • Provide blood and tissue linked to clinical and biologic information for translational studies.


-Progression free survival, measured as the time from diagnosis to the development of active disease that requires treatment at which time patients will be able to change to a treatment protocol or seek treatment outside of NIH.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

    1. Diagnosis of CLL/SLL will be made according to the updated criteria of the NCI Working Group.


      Diagnosis of MBL according to the updated criteria of the NCI Working Group and the absence of pathologic lymphadenopathy or autoimmune disease.


      Diagnosis of LPL/WM according to the consensus panel criteria from the International Workshop on Waldenstrom's Macroglobulinemia.


      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 who have received previous cytotoxic, monoclonal antibody, or kinase inhibitor therapy for CLL/SLL/LPL/WM/SMZL.
  2. Patients with HIV/AIDS.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00923507

Contact: Susan Soto, R.N. (301) 402-0797
Contact: Clare C Sun, M.D. (301) 451-7130

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
Principal Investigator: Clare C Sun, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ) Identifier: NCT00923507     History of Changes
Obsolete Identifiers: NCT00769743
Other Study ID Numbers: 080105, 08-H-0105
Study First Received: June 17, 2009
Last Updated: August 27, 2015
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Gene Expression
Watch and Wait
Molecular Genetics
Biologic Markers

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Leukocyte Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Vascular Diseases processed this record on August 27, 2015