Protocol Details
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 currently recruiting participants.
Summary
Number |
08-H-0105 |
Sponsoring Institute |
National Heart, Lung and Blood Institute (NHLBI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: 110 Years |
Referral Letter Required |
Yes |
Population Exclusion(s) |
Children |
Keywords |
Chronic Lymphocytic Leukemia (CLL);
Monoclonal B Cell Lymphocytosis;
Small Lymphocytic Lymphoma (SLL);
Natural History |
Recruitment Keyword(s) |
Leukemia;
Lymphoma |
Condition(s) |
Waldenstrom Macroglobulinemia;
Lymphoplasmacytic Lymphoma;
Monoclonal B-Cell Lymphocytosis;
Small Lymphocytic Lymphoma;
CLL (Chronic Lymphocytic Leukemia) |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Heart, Lung, and Blood Institute |
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
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT00923507