RecruitingNot Applicable

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)

United States1,000 participantsStarted 2008-05-29

Plain-language 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.

Who can participate

Age range

18 Years – 110 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of CLL/SLL will be made according to the updated criteria of the NCI Working Group.
. 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 informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a natural history study and not a treatment trial, what does participation actually involve day-to-day — things like how often I'd need to come in for visits, what samples or tests would be collected, and how long I'd be followed?
2My diagnosis falls into one of the conditions this study is watching over time — like CLL, SLL, or Waldenstrom Macroglobulinemia — so would joining this study delay or interfere with starting active treatment if my disease progresses and I need it sooner than expected?
3Because this study is focused on observing the disease before treatment is needed, does it mean I'd need to be in a 'watch and wait' phase to be eligible, and how does that fit with where my disease stands right now?
4What kind of information would the researchers be collecting about my disease, and could participating give me or my care team earlier insight into how my specific condition is progressing compared to what I'd get from routine follow-up alone?
5Are there standard monitoring approaches or other observational programs my doctor already uses for conditions like mine, and how would joining this NIH natural history study compare to or complement what I'd receive through my regular care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Study the natural history of MBL/CLL/SLL in patients prior to the time when their disease requires treatment.

Timeframe: Ongoing

Trial details

NCT IDNCT00923507

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Contact for this trial

Ingrid C Frey

(301) 402-0797 ingrid.frey@nih.gov

View on ClinicalTrials.gov More Waldenstrom Macroglobulinemia trials