Recruiting

Observational Study

Sponsor:

National Heart, Lung, and Blood Institute (NHLBI)

Code:

NCT00923507

Conditions

Waldenstrom Macroglobulinemia

Lymphoplasmacytic Lymphoma

Monoclonal B-Cell Lymphocytosis

Small Lymphocytic Lymphoma

CLL (Chronic Lymphocytic Leukemia)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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 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.

Conditions

Waldenstrom Macroglobulinemia

Lymphoplasmacytic Lymphoma

Monoclonal B-Cell Lymphocytosis

Small Lymphocytic Lymphoma

CLL (Chronic Lymphocytic Leukemia)

Study ID

NCT00923507

Start date

May 29, 2008

Status verified date

Aug 19, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

-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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Primary outcome measure

  • Study the natural history of MBL/CLL/SLL in patients prior to the time when their disease requires treatment. [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

More Information

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Last update posted

Sep 1, 2026

Last verified

Aug 19, 2026

Keywords

  • Chronic Lymphocytic Leukemia (CLL)
  • Monoclonal B Cell Lymphocytosis
  • Small Lymphocytic Lymphoma (SLL)
  • Natural History
  • Leukemia
  • Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Heart, Lung, and Blood Institute (NHLBI) on 2026-09-01.