NCT00923507 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)
| NCT ID | NCT00923507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Waldenstrom Macroglobulinemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2008-05-29 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2008-05-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. ...
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
Contact & Investigator
Adrian U Wiestner, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT00923507 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Waldenstrom Macroglobulinemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00923507 currently recruiting?
Yes, NCT00923507 is actively recruiting participants. Contact the research team at ingrid.frey@nih.gov for enrollment information.
Where is the NCT00923507 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00923507 clinical trial?
NCT00923507 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Adrian U Wiestner, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 1,000 participants.