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
2 other identifiers
observational
20
1 country
1
Brief Summary
Background:
- Chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL) are types of cancers in which there are too many abnormal lymphocytes (a type of white blood cell). Monoclonal B-cell lymphocytosis (MBL) is a condition in which the individual has a larger than normal number of lymphocytes. Individuals with CLL, SLL, MBL, and MCL may survive for many years without the need for treatment, but there is an apparent correlation between cell birth rates and disease activity. By studying the birth and death rates of lymphocytes, researchers hope to identify individuals who are at risk for worsening disease.
- Heavy water is similar in structure to regular water, but it has two deuterium atoms instead of two hydrogen atoms. Deuterium has one more neutron than hydrogen, which is what makes heavy water heavy. Heavy water is not radioactive, looks and tastes like regular water, and has no known harmful effects at research-level doses. When a small amount of heavy water is consumed daily, newly produced blood cells are labeled (tagged), which allows researchers to track cell growth and to measure the birth and death rates of CLL, SLL, MBL, MCL or normal lymphocytes. Objectives: \- To study the birth and death rates of lymphocytes from individuals with MBL, CLL/SLL, and MCL, compared with lymphocytes from healthy volunteers. Eligibility:
- Individuals at least 18 years of age who have been diagnosed with MBL, CLL, SLL, or MCL, but who have not been taking certain agents (Viagra, Levitra, Cialis, or other PDE-inhibitors, prednisone, cyclosporin-A, rapamycin, or other immunosuppressive agents, more than 2 cups of green tea daily, or Celebrex) for 4 weeks prior to enrollment in the study.
- Healthy volunteers at least 18 years of age, but who have not been taking certain agents (Viagra, Levitra, Cialis, or other PDE-inhibitors, prednisone, cyclosporin-A, rapamycin, or other immunosuppressive agents, more than 2 cups of green tea daily, or Celebrex)for 4 weeks prior to enrollment in the study. Design:
- Participants will be screened with a medical history, physical examination, and initial blood tests. Other tests may be administered to the individuals with cancer, as required by the study researchers.
- All participants will drink regular doses of heavy water daily for a total of 4 weeks (labeling period). There is an optional 6-month follow-up or wash-out period during which no additional heavy water will be consumed.
- Blood samples will be collected weekly during the labeling period, and a bone marrow biopsy will be obtained where possible. Individuals with cancer may also have a lymph node biopsy during this part of the study.
- Additional blood samples may be collected during the optional wash-out phase of the study to determine the rate at which cancer cells disappear.
- Treatment is not provided as part of this protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2010
CompletedFirst Posted
Study publicly available on registry
May 5, 2010
CompletedStudy Start
First participant enrolled
June 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2020
CompletedJuly 14, 2020
July 1, 2020
10.1 years
May 4, 2010
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the estimate of the cell proliferation rate of tumor cells in individuals with MBL, CLL/SLL, and MCL
Cell proliferation rate of tumor cells
28 days
Secondary Outcomes (1)
Secondary endpoints include: Proliferation rate in tissue compared to blood, disappearance rate of labeled cells from the blood and tissue and the safety profile of heavy water in the study population/
28 to 196 days
Study Arms (4)
CLL/SLL
Chronic lymphocytic leukemia/small lymphocytic lymphoma
Healthy Volunteers
Healthy Volunteers
MBL
Monoclonal B-cell lymphocytosis
MCL
Mantle Cell Lymphoma
Eligibility Criteria
All patients with eligible conditions or healthy volunteers aged 18 and over if participating as a normal volunteer who otherwise fulfill the eligibility criteria will be considered for the protocol.
You may qualify if:
- \<TAB\>Diagnosed with MBL, CLL/SLL, or MCL
- \<TAB\>Greater than or equal to 18 years of age
- \<TAB\>Neutrophil count (ANC) greater than or equal to 1000/mcL
- \<TAB\>Platelet count greater than or equal to 50K/mcL
You may not qualify if:
- \<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
- \<TAB\>Chronic or current clinically significant infection, including HIV or uncontrolled infection
- \<TAB\>Receiving concurrent anticancer therapies
- \<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
- \<TAB\>Sexually active males who are unwilling to follow the strict contraception requirements described in this protocol.
- \<TAB\>Inability to understand the investigational nature of the study, inability to provide informed consent
- \<TAB\>Health status will be confirmed by brief History and Physical Exam and blood work
- \<TAB\>Greater than or equal to 18 years of age
- \<TAB\>CBC and coagulation panel within the expected normal ranges for the subject
- \<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)
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Related Publications (3)
Hallek M, Bergsagel PL, Anderson KC. Multiple myeloma: increasing evidence for a multistep transformation process. Blood. 1998 Jan 1;91(1):3-21.
PMID: 9414264BACKGROUNDJemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
PMID: 19474385BACKGROUNDRedaelli A, Laskin BL, Stephens JM, Botteman MF, Pashos CL. A systematic literature review of the clinical and epidemiological burden of acute lymphoblastic leukaemia (ALL). Eur J Cancer Care (Engl). 2005 Mar;14(1):53-62. doi: 10.1111/j.1365-2354.2005.00513.x.
PMID: 15698386BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clare C Sun, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2010
First Posted
May 5, 2010
Study Start
June 3, 2010
Primary Completion
July 10, 2020
Study Completion
July 10, 2020
Last Updated
July 14, 2020
Record last verified: 2020-07