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. (see Contacts and Locations)
Verified August 2015 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT00923507
First received: June 17, 2009
Last updated: September 30, 2015
Last verified: August 2015
  Purpose

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 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)
    • 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.

Condition
B-Cell Chronic Lymphocytic Leukemia
Monoclonal B-Cell Lymphocytosis
Lymhoma, Small Lymphocytic
Chronic Lymphocytic Leukemia
Lymphoplasmacytic Lymphoma
Waldenstrom Macroglobulinemia
Splenic Marginal Zone Lymphoma

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: 550
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.

  • 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 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.

  • Objectives:

    • Describe the natural history of MBL/CLL/SLL 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 by studying MBL/CLL/SLL and closely related B-cell malignancies, LPL/WM and SMZL
    • 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.
  • Endpoints:

    • In patients with CLL/SLL: 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.
    • In patients with LPL/WM/SMZL: treatment free survival, measured as the time from last therapy 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.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

    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.

EXCLUSION CRITERIA:

  1. Patients with CLL/SLL who have received previous cytotoxic, monoclonal antibody, or kinase inhibitor therapy.
  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 ClinicalTrials.gov identifier: NCT00923507

Contacts
Contact: Susan Soto, R.N. (301) 402-0797 sotos@nhlbi.nih.gov
Contact: Clare C Sun, M.D. (301) 451-7130 clare.sun@nih.gov

Locations
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    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Clare C Sun, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT00923507     History of Changes
Obsolete Identifiers: NCT00769743
Other Study ID Numbers: 080105  08-H-0105 
Study First Received: June 17, 2009
Last Updated: September 30, 2015
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphocytosis
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Waldenstrom Macroglobulinemia
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Leukocyte Disorders
Leukocytosis
Lymphatic Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Plasma Cell
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on February 07, 2016