Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
National Heart, Lung, and Blood Institute (NHLBI)
Summary
Background: Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. Pirtobrutinib is a drug approved to treat CLL and SLL after 2 previous treatments. Researchers want to know how this drug affects the immune system in those who have not yet started other treatments for CLL or SLL. Objective: To test pirtobrutinib as a first-line treatment for CLL or SLL. Eligibility: People aged 18 years and older with untreated CLL or SLL. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans and tests of their heart function. They will have a lymph node biopsy: A large needle will be inserted into a lymph node to collect a small piece of tissue. Pirtobrutinib is a tablet taken by mouth. Participants will take 2 to 4 tablets daily in 4-week cycles. Participants will have clinic visits once every 4 weeks for the first 3 months. Then they will be seen once every 3 months. Imaging scans, lymph node biopsy, and other tests will be repeated at various study visits. A bone marrow biopsy (collection of soft tissue from inside a bone) may be done if there is no evidence of disease after 1 year of treatment with the study drug. Participants may opt to have cancer and immune cells collected from their blood. The cells will be used for research. Participants will have a clinic visit 1 month after their last dose of the study drug. Then they will have follow-up visits or phone calls every 6 to 12 months....
Description
Study Description: This is a pilot study of pirtobrutinib for previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). Subjects will be treated with pirtobrutinib 200 mg by mouth once daily until disease progression or toxicity. Immune profiling of lymph node (LN) and peripheral blood (PB) will be performed at baseline and on pirtobrutinib. Circulating tumor cells will be analyzed at baseline and on pirtobrutinib. Efficacy and safety will be evaluated. Objectives: Primary Objective: -Evaluate the immune cell composition of LN at baseline and on pirtobruti…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Stated willingness to comply with all study procedures 2. Age \>=18 years 3. Confirmed diagnosis of CLL or SLL according to International Workshop on CLL (iwCLL) guidelines 1. Coexpression of CD5, CD19, CD20, and CD23 expression and light-chain restriction; CD23 dim or negative expression is acceptable as long as other parameters are consistent with a diagnosis of CLL. 2. CLL: clonal B-lymphocytosis \>=5,000 cells/mL OR SLL: lymphadenopathy with…
Interventions
- DrugPirtobrutinib
Pirtobrutinib will be administered orally at a dose of 200 mg once daily in 28-day cycles
Location
- National Institutes of Health Clinical CenterBethesda, Maryland