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Estudo da História Natural da Linfocitose Monoclonal de Células B (MBL), Leucemia Linfocítica Crônica/Linfoma Linfocítico Pequeno (CLL/SLL), Linfoma Linfoplasmocítico (LPL)/Macroglobulinemia de Waldenstrom (WM) e Linfoma Esplênico da Zona Marginal (SMZL)

4 de novembro de 2026 atualizado por: National Heart, Lung, and Blood Institute (NHLBI)

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.

...

Visão geral do estudo

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

1000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • Recrutamento
        • National Institutes of Health Clinical Center
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 110 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

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).

Descrição

-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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Modelos de observação: COHORT
  • Perspectivas de Tempo: PROSPECTIVE

Coortes e Intervenções

Grupo / Coorte
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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Study the natural history of MBL/CLL/SLL in patients prior to the time when their disease requires treatment.
Prazo: Ongoing

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 able to change to a treatment protocol or seek treatment outside of NIH.

Ongoing

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Characterize clinical, biological and molecular events of disease stability and progression of patients enrolled on this protocol
Prazo: Ongoing

Describe the underlying biologic heterogeneity of tumor cells in relation to treatment free survival

Ongoing

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Adrian U Wiestner, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de maio de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

17 de junho de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de junho de 2009

Primeira postagem (Estimado)

18 de junho de 2009

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de novembro de 2026

Última verificação

8 de setembro de 2026

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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