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Natural History Study of Monoclonal B Cell Lymphocytosis (MBL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)


N/A
18 Years
N/A
Open (Enrolling)
Both
B-Cell Chronic Lymphocytic Leukemia, Monoclonal B-Cell Lymphocytosis, Lymhoma, Small Lymphocytic, Chronic Lymphocytic Leukemia

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Trial Information

Natural History Study of Monoclonal B Cell Lymphocytosis (MBL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)


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) and chronic lymphocytic leukemia/small lymphoma (CLL/SLL)

Assessments will be used for clinical and translational research investigating the molecular
basis of Monoclonal B cell lymphocytosis (MBL) and Chronic Lymphocytic Leukemia (CLL)/Small
Lymphocytic Lymphoma (SLL) 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 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 is an incurable disease for
which there are no 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

- Age greater than or equal to 18 years.

- Patients must have received no previous cytotoxic or monoclonal antibody therapy for
CLL/SLL.

- ECOG performance status of 0-2.

Design:

-Patients will be followed as needed and clinically indicated; typically this will include
visits between every 3-24 months. 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 natural history of MBL/CLL/SLL in patients prior to the time when their
disease requires treatment.

- Apply the expertise and available technologies of the investigators to advance our
understanding of disease pathogenesis and develop novel treatment approaches for
CLL/SLL.

- Provide evaluation, diagnostic studies and monitoring for patients on study.

- Provide blood and tissue linked to clinical and biologic information for translational
studies.

Endpoints:

-Progression free survival, measured as the time from diagnosis to the development of active
disease that requires treatment at which tie patients will be able to change to a treatment
protocol or seek treatment outside of NIH.

Inclusion Criteria


- 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.

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 who have received previous cytotoxic or monoclonal antibody therapy for
CLL/SLL.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Principal Investigator

Adrian U Wiestner, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)

Authority:

United States: Federal Government

Study ID:

080105

NCT ID:

NCT00923507

Start Date:

April 2008

Completion Date:

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Monoclonal B-Cell Lymphocytosis
  • Lymhoma, Small Lymphocytic
  • Chronic Lymphocytic Leukemia
  • Gene Expression
  • Prognosis
  • Watch and Wait
  • Molecular Genetics
  • Biologic Markers
  • Leukemia
  • Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphocytosis
  • Lymphoma

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892