Clinical Trial: 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)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma(CLL/SLL), Lmphoplasmacytic Lymphoma(LPL)/Waldenstro

Brief Summary:

Background:

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.

  • Objectives:

    • Study the biology and natural history of MBL/CLL/SLL in patients prior to the time when their disease requires treatment and the biology of LPL/WM and SMZL.
    • Characterize clinical, biologic and molecular events of disease stability and progression of patients enrolled on this protocol.

  • Eligibility:

    • Diagnosis of MBL/CLL/SLL/LPL/WM/SMZL
    • Age greater than or equal to 18 years.
    • Patients with CLL/SLL must not have received previous cytotoxic, monoclonal antibody, or kinase inhibitor therapy.
    • Patients with LPL/WM or SMZL can have prior therapy.
    • ECOG performance status of 0-2.

  • Design:

    • Patients are typically followed every 6 to

      Detailed Summary:

      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.

      • Eligibility:

        • Diagnosis of MBL/CLL/SLL/LPL/WM/SMZL
        • Age greater than or equal to 18 years.
        • Patients with CLL/SLL must not have received previous cytotoxic, monoclonal antibody, or kinase inhibitor therapy.
        • Patients with LPL/WM or SMZL can have prior therapy.
        • ECOG performance status of 0-2.
      • Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

        Current Primary Outcome:

        Original Primary Outcome:

        Current Secondary Outcome:

        Original Secondary Outcome:

        Information By: National Institutes of Health Clinical Center (CC)

        Dates:
        Date Received: June 17, 2009
        Date Started: April 4, 2008
        Date Completion:
        Last Updated: April 26, 2017
        Last Verified: April 14, 2017