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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)

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ClinicalTrials.gov Identifier: NCT00923507
Recruitment Status : Recruiting
First Posted : June 18, 2009
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date June 17, 2009
First Posted Date June 18, 2009
Last Update Posted Date June 2, 2020
Actual Study Start Date May 29, 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: August 7, 2019)
Describe the history of MBL/CLL/SLL /WM/SMZL in patients prior to and after treatment. [ Time Frame: Ongoing ]
Treatment free survival, measured as the time from diagnosis or 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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: July 12, 2018)
Characterize clinical, biological and molecular events of disease stability and progression of patients enrolled on this protocol [ Time Frame: Ongoing ]
Describe the underlying biologic heterogeneity of tumor cells in relation to treatment free survival
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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)
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 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.
  • Eligibility:

    • 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.
  • 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.
    • 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.
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)/Waldenstrom 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.
    • 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 history of MBL/CLL/SLL/WM/SMZL in patients prior to and after 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:

    • Treatment free survival, measured as the time from dianosis or 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.
    • Describe the underlying biologic heterogeneity of tumor cells in relation to treatment free survival.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstr(SqrRoot)(Delta)m macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL).
Condition
  • Waldenstrom Macroglobulinemia
  • Lymphoplasmacytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Monoclonal B-Cell Lymphocytosis
  • Small Lymphocytic Lymphoma
  • CLL (Chronic Lymphocytic Leukemia)
Intervention Not Provided
Study Groups/Cohorts Patients
Patients with monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstr(SqrRoot)(Delta)m macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 18, 2015)
550
Original Enrollment
 (submitted: June 17, 2009)
230
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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 in remission following previous chemotherapy.
  2. Patients with HIV/AIDS.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 110 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Susan Soto, R.N. (301) 402-0797 sotos@nhlbi.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00923507
Other Study ID Numbers 080105
08-H-0105
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: Clare C Sun, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date August 13, 2019