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)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 110
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
National Heart, Lung, and Blood Institute (NHLBI) · NIH
Who this trial is looking for
This trial is looking for adults with certain types of blood cancer. Participants will be monitored over time and may undergo various tests to track their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma.
I am currently receiving treatment or have been treated before.
I am nearing my first treatment.
I have been diagnosed with lymphoplasmacytic lymphoma or Waldenstrom macroglobulinemia.
I have an ECOG performance status of 0-2.
I can understand the purpose of this trial and give my consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 st…
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.
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Trial Locations
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Eligibility Criteria
-INCLUSION CRITERIA:
1. Diagnosis of CLL/SLL will be made according to the updated criteria of the NCI Working 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 …
-INCLUSION CRITERIA:
1. Diagnosis of CLL/SLL will be made according to the updated criteria of the NCI Working 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 of bone marrow infiltration by small lymphocytes showing plasmacytoid/plasma cell differentiation. WM, comprising \>95% of LPL cases, describes the clinical syndrome of LPL associated with an IgM monoclonal gammopathy of any concentration. The remaining cases may be IgA, IgM, or non-secreting LPL. Immunophenotyping is required for diagnosis
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\. None
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