What's the purpose of this trial?
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 clarify 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 MBL/CLL/SLL/LPL/WM/SMZL
* Age greater than or equal to 18 years.
* Patients with CLL/SLL in remission after chemotherapy are excluded.
* ECOG performance status of 0-2.
* Design:
* Patients are typically followed every 6 to 24 months in the clinic and have blood drawn. When required patients may undergo additional testing that may include bone marrow biopsy and aspiration, blood drawing, lymph node biopsy, x-ray studies, positron emission tomography and CT and MRI scans. Some of these tests may be required to monitor CLL/SLL, LPL/WM, and SMZL patients. Other tests, such as bone marrow biopsy and aspiration, 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.
This trial is currently open and accepting patients.
What will happen during the trial?
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
required.
* INCLUSION CRITERIA:
1. Diagnosis of CLL/SLL will be made according to the updated criteria of the NCI Working Group. OR Diagnosis of MBL according to the updated criteria of the NCI Working Group and the absence of pathologic lymphadenopathy or autoimmune disease. OR Diagnosis of LPL/WM according to the consensus panel criteria from the International Workshop on Waldenstrom's Macroglobulinemia. OR
Diagnosis of SMZL as outlined by Matutes, et al.
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. Patients with CLL/SLL in remission following previous chemotherapy.
Additional Trial Information
Observational Trial
Enrollment: 1,000 patients (estimated)
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