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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Collaborator: |
National Heart Lung and Blood |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00923507 |
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:
Eligibility:
-Patients 18 years of age or older diagnosed with either MBL or CLL/SLL.
Design:
| Condition |
|---|
|
B-cell Chronic Lymphocytic Leukemia Monoclonal B-Cell Lymphocytosis Lymhoma, Small Lymphocytic Chronic Lymphocytic Leukemia |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Natural History Study of Monoclonal B Cell Lymphocytosis (MBL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) |
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | January 2018 (Final data collection date for primary outcome measure) |
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:
Design:
-Patients will be followed as needed and clinically indicated; typically this will include visits between every 3-12 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:
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 |
INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
1. Patients who have received previous cytotoxic or monoclonal antibody therapy for CLL/SLL.
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
More Information
| Study ID Numbers: | 080105, 08-H-0105 |
| Study First Received: | June 17, 2009 |
| Last Updated: | October 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00923507 History of Changes |
| Health Authority: | United States: Federal Government |
|
Gene Expression Prognosis Watch and Wait Molecular Genetics |
Biologic Markers Leukemia Lymphoma |
|
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Leukocyte Disorders Leukemia Lymphatic Diseases |
Neoplasms Leukocytosis Lymphocytosis Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Lymphoproliferative Disorders Lymphoma |