Observing the natural history of certain blood cancers
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)
This study is tracking how certain blood cancers develop over time in patients to learn more about them and find new treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00923507 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the natural history 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). It will collect blood, tissue samples, and imaging studies from patients to characterize clinical, biological, and molecular events related to disease stability and progression. Patients will be followed over time to gather data that could lead to the discovery of new treatment targets and a better understanding of these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with CLL/SLL, LPL, WM, or SMZL, either currently on treatment or previously treated.
Not a fit: Patients with conditions other than MBL, CLL, SLL, LPL, WM, or SMZL may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and potential new treatment options for patients with these blood cancers.
How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown promise in understanding the progression of blood cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Adrian U Wiestner, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Ingrid C Frey
- Email: ingrid.frey@nih.gov
- Phone: (301) 402-0797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.