A Study of the Kinetics of Lymphoid Cells in Patients With Monoclonal B-cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL) and Healthy Volunteers

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · May 4, 2010

Keywords

ClinConnect Summary

Chronic lymphocytic leukemia (CLL) and its lymphoma variant, small lymphocytic lymphoma (SLL) were for decades considered diseases caused by the progressive accumulation of abnormal lymphocytes. The prevailing view being that CLL and SLL disease processes were driven by an underlying defect in apoptosis. While resistance to apoptosis appears to be important in the CLL and SLL disease process, recent studies suggest that cellular proliferation is more important than previously realized.

Cells from individuals with CLL who drank deuterated water (heavy water) for 6 weeks showed a turnover ra...

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA: (MBL, CLL/SLL, MCL group)
• • 4.1.1.\<TAB\>Diagnosed with MBL, CLL/SLL, or MCL
• • 4.1.2.\<TAB\>Greater than or equal to 18 years of age
• • 4.1.3.\<TAB\>Neutrophil count (ANC) greater than or equal to 1000/mcL
• • 4.1.4.\<TAB\>Platelet count greater than or equal to 50K/mcL
• • EXCLUSION CRITERIA: (MBL, CLL/SLL, MCL group)
• • 4.2.1.\<TAB\>Concomitant use of agents that have been described to affect the biology and/or proliferation rate of CLL cells but are not approved or accepted therapies for CLL, SLL, MCL, or MBL
• • PDE-inhibitors (e.g. sildenafil, theophylline)
• • Immunosuppressive agents (e.g., prednisone, cyclosporin-A, rapamycin)
• • Green Tea extract (more than 2 cups per day)
• • Cox-2 inhibitors
• • 4.2.2.\<TAB\>Chronic or current clinically significant infection, including HIV or uncontrolled infection
• • 4.2.3.\<TAB\>Receiving concurrent anticancer therapies
• • 4.2.4.\<TAB\>Women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use a an agreed upon form of contraception for the duration of participation in this study
• • 4.2.5\<TAB\>Sexually active males who are unwilling to follow the strict contraception requirements described in this protocol.
• • 4.2.6\<TAB\>Inability to understand the investigational nature of the study, inability to provide informed consent
• • INCLUSION CRITERIA: (Healthy volunteer group)
• • 4.3.1\<TAB\>Health status will be confirmed by brief History and Physical Exam and blood work
• • 4.3.2\<TAB\>Greater than or equal to 18 years of age
• • 4.3.3\<TAB\>CBC and coagulation panel within the expected normal ranges for the subject
• • EXCLUSION CRITERIA: (Healthy volunteer group)
• • 4.4.1.\<TAB\>Concomitant use of agents that have been described to affect the biology and/or proliferation rate of CLL cells
• • PDE-inhibitors (e.g. , slidenafil, theophylline)
• • Immunosuppressive agents (e.g., cyclosporin-A, rapamycin)
• • Green Tea extract (more than 2 cups per day)
• • Cox-2 inhibitors
• • \<TAB\>
• • 4.4.2.\<TAB\>Women who are pregnant or nursing, as well as women of childbearing potential who are unwilling to use an agreed upon form of contraception for the duration of study participation.
• • 4.4.3\<TAB\> Sexually active males who are unwilling to follow the strict contraception requirements described in this protocol.
• • 4.4.4.\<TAB\>Inability to understand the investigational nature of the study, inability to provide informed consent