Clinical trial · Observational
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
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CLL (Chronic Lymphocytic Leukemia) | Chronic Lymphocytic Leukemia | ALIAS | 0.85 |
| Healthy Volunteers | — | UNRESOLVED | — |
| Lymphoma, Mantle-cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Monoclonal B-Cell Lymphocytosis | Monoclonal B-Cell Lymphocytosis | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- CLL/SLL
- description
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- label
- Healthy Volunteers
- description
- Healthy Volunteers
- label
- MBL
- description
- Monoclonal B-cell lymphocytosis
- label
- MCL
- description
- Mantle Cell Lymphoma
Primary outcomes (1)
- measure
- The primary endpoint is the estimate of the cell proliferation rate of tumor cells in individuals with MBL, CLL/SLL, and MCL
- timeFrame
- 28 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
* 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
References
Publications (3)
- BACKGROUNDHallek M, Bergsagel PL, Anderson KC. Multiple myeloma: increasing evidence for a multistep transformation process. Blood. 1998 Jan 1;91(1):3-21. PMID 9414264
- BACKGROUNDJemal 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 19474385
- BACKGROUNDRedaelli 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 15698386