Natural History Study of Monoclonal B Cell Lymphocytosis and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This study is currently recruiting participants.
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00923507
First received: June 17, 2009
Last updated: March 14, 2014
Last verified: November 2013
  Purpose

Background:

-The development of new technologies now allow scientists to investigate the genetic basis of monoclonal B cell lymphocytosis (MBL) and chronic lymphocytic leukemia(CLL)/Small lymphocytic lymphoma (SLL) and their clinical manifestations. Applying these methods in a natural history study can clarify processes involved in disease progression and possibly lead to the discovery or validation of treatments.

Objectives:

  • To describe the natural course of MBL and CLL/SLL in patients before they need treatment.
  • To characterize in each patient the clinical, biologic and molecular events of disease stability and progression.

Eligibility:

-Patients 18 years of age or older diagnosed with either MBL or CLL/SLL.

Design:

  • Patients are followed every 3 to 12 months with tests that may include bone marrow biopsy and aspiration, blood drawing, lymph node biopsy, x-ray studies, positron emission tomography and CT scans of the neck, chest, abdomen, and pelvis. Because these tests are routinely done to monitor MBL and CLL/SLL, participants need not undergo additional tests specifically for research. (Bone marrow biopsy and aspiration and lymph node biopsy are often not required to diagnose CLL/SLL, but patients may be asked to undergo these procedures for research purposes in this study.)
  • Clinical information is collected and stored in a central databank.
  • Patients whose cancer requires treatment will be taken off the study and treatment options will be discussed with them. If no NIH treatment protocols are available to them, they will be returned to the care of their local physician.

Condition
B-Cell Chronic Lymphocytic Leukemia
Monoclonal B-Cell Lymphocytosis
Lymhoma, Small Lymphocytic
Chronic Lymphocytic Leukemia

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Natural History Study of Monoclonal B Cell Lymphocytosis (MBL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 250
Study Start Date: April 2008
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) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923507

Contacts
Contact: Susan Soto, R.N. (301) 402-0797 jordansk@cc.nih.gov
Contact: Adrian U Wiestner, M.D. (301) 594-6855 wiestnera@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Adrian U Wiestner, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00923507     History of Changes
Obsolete Identifiers: NCT00769743
Other Study ID Numbers: 080105, 08-H-0105
Study First Received: June 17, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Gene Expression
Prognosis
Watch and Wait
Molecular Genetics
Biologic Markers
Leukemia
Lymphoma

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphocytosis
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukocytosis
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014