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)

Phase

N/A

Condition

Lymphoproliferative Disorders

Chronic Lymphocytic Leukemia

Leukemia (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00923507

080105

08-H-0105

Ages 18-110
All Genders

Study 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 help identify 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 CLL/SLL and on treatment/previously treated/nearing treatment
Diagnosis of LPL/WM
As of February 5, 2025, patients with MBL and SMZL will no longer be enrolled.
Age greater than or equal to 18 years.
ECOG performance status of 0-2.

Design

Patients are typically followed every 6 to 24 months in the clinic and have blood drawn. Patients may be asked to undergo additional testing, including bone marrow biopsy and aspiration, lymph node biopsy, positron emission tomography, and CT and MRI scans. Some of these tests (e.g., blood draw) may be required to monitor CLL/SLL and LPL/WM. Other tests (e.g., 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.

Eligibility Criteria

Inclusion

-INCLUSION CRITERIA:

Diagnosis of CLL/SLL will be made according to the updated criteria of the NCIWorking Group.

on treatment or previously treated
requiring or nearing first-line treatment OR Diagnosis of LPL/WM. LPL is defined as the presence of an intertrabecular pattern ofbone marrow infiltration by small lymphocytes showing plasmacytoid/plasma celldifferentiation. WM, comprising >95% of LPL cases, describes the clinical syndromeof LPL associated with an IgM monoclonal gammopathy of any concentration. Theremaining cases may be IgA, IgM, or non-secreting LPL. Immunophenotyping is requiredfor diagnosis

Age greater than or equal to 18 years.
ECOG performance status of 0-2.
Able to comprehend the investigational nature of the protocol and provide informedconsent

Exclusion

EXCLUSION CRITERIA:

None

Study Design

May 29, 2008

Study 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 lymphocytic 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 diagnosis or last therapy to the development of active disease that requires treatment at which time patients will be evaluated for a treatment protocol or seek treatment outside of NIH.

Connect with a study center

National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United States
Active - Recruiting

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