Healthy Volunteers Clinical Trial
Official title:
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.
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.
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 rate of 0.1 % to 1.1 % per day. In a second study involving CLL subjects who drank
heavy water, average CLL turnover rates were in a similar range but approximately 2-fold
lower than average B-cell turnover rates from healthy individuals. These studies have shown
the safety and scientific value of using heavy water to study the kinetics of cell
proliferation in patients and normal volunteers.
We now propose this study to expand on findings by other investigators. This study will
address the site of proliferation for CLL/SLL cells and will include individuals with
monoclonal B-cell lymphocytosis (MBL), a possible precursor of CLL. Furthermore, we will
include patients with mantle cell lymphoma (MCL), a disease in which tumor proliferation
plays an important role.
Study participants will drink heavy water daily for a total of 4 weeks (labeling period) with
an optional 6 months follow up ( wash out period). Blood samples will be obtained weekly
during the labeling period. A bone marrow and/or lymph node biopsy will be obtained where
possible during the labeling period. Additional blood draws may be obtained during the
optional wash-out phase of the study to determine the rate at which tumor cells disappear.
The primary objective of this exploratory study is to obtain an estimate of the proliferation
rate of tumor cells in individuals with MBL, CLL/SLL, and MCL. Secondary objectives include
the comparison of proliferation rates between different anatomic compartments, specifically
peripheral blood, lymph node, and bone marrow and the estimation of the attrition or
disappearance rate of cells during an optional phase of the protocol. Healthy volunteers may
be included for comparison.
The primary objective of this exploratory study is to obtain an estimate of the proliferation
rate of tumor cells in individuals with MBL, CLL/SLL, and MCL.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |