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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)

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Jun 17, 2009

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Chronic Lymphocytic Leukemia (Cll) Monoclonal B Cell Lymphocytosis Small Lymphocytic Lymphoma (Sll) Natural History Leukemia Lymphoma

ClinConnect Summary

This clinical trial is studying different blood cancers, including 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). The goal is to understand how these conditions develop and progress over time, both before and after treatment. By doing this, researchers hope to identify new targets for treatment that could help patients in the future.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of one of the mentioned conditions. However, those who are in remission from CLL/SLL after chemotherapy are not eligible. During the study, participants will have regular check-ups—typically every 6 to 24 months—where they will provide blood samples and may undergo additional tests like imaging scans or biopsies, although no treatment will be given as part of this study. If a participant needs treatment, they will be informed about other clinical trials or options available to them.

Gender

ALL

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 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

About National Heart, Lung, And Blood Institute (Nhlbi)

The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

Patients applied

CW

1 patients applied

Trial Officials

Clare C Sun, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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