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)

Sponsor
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT00923507
Collaborator
(none)
1,000
1

Study Details

Study Description

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 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.

Detailed Description

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 dianosis 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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)
Actual Study Start Date :
May 29, 2008

Arms and Interventions

Arm Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

  1. Study the natural history of MBL/CLL/SLL in patients prior to the time when their disease requires treatment. [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.

Secondary Outcome Measures

  1. Characterize clinical, biological and molecular events of disease stability and progression of patients enrolled on this protocol [Ongoing]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • 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.

  1. Age greater than or equal to 18 years.

  2. ECOG performance status of 0-2.

  3. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

Sponsors and Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Clare C Sun, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00923507
Other Study ID Numbers:
  • 080105
  • 08-H-0105
  • NCT00769743
First Posted:
Jun 18, 2009
Last Update Posted:
Jul 7, 2022
Last Verified:
May 4, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2022