Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Étude de l'histoire naturelle de la lymphocytose monoclonale à cellules B (MBL), de la leucémie lymphoïde chronique/lymphome lymphocytaire à petits caractères (CLL/SLL), du lymphome lymphoplasmocytaire (LPL)/macroglobulinémie de Waldenstrom (WM) et du lymphome de la zone marginale splénique (SMZL)

10 novembre 2026 mis à jour par: 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.

...

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

1000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

    • Maryland
      • Bethesda, Maryland, États-Unis, 20892
        • Recrutement
        • National Institutes of Health Clinical Center
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 110 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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).

La description

-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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Study the natural history of MBL/CLL/SLL in patients prior to the time when their disease requires treatment.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Characterize clinical, biological and molecular events of disease stability and progression of patients enrolled on this protocol
Délai: Ongoing

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

Ongoing

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 mai 2008

Dates d'inscription aux études

Première soumission

17 juin 2009

Première soumission répondant aux critères de contrôle qualité

17 juin 2009

Première publication (Estimé)

18 juin 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

12 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 novembre 2026

Dernière vérification

6 novembre 2026

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner