Actively Recruiting
Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-03-13
30
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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....
CONDITIONS
Official Title
Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to comply with all study procedures
- Age 18 years or older
- Confirmed diagnosis of CLL or SLL following iwCLL guidelines
- Active disease requiring treatment according to iwCLL guidelines
- Measurable disease with at least one of: lymph node ≥1.5 cm, spleen >13 cm, lymphocytosis ≥5,000 B cells/µL, or bone marrow infiltration ≥30%
- Previously untreated CLL with at least one lymph node suitable for core-needle biopsy
- ECOG performance status of 0-2
- Adequate liver function: ALT or AST ≤3x ULN (or ≤5x ULN with liver involvement), total bilirubin ≤1.5x ULN (or ≤3x ULN with liver involvement)
- Adequate kidney function: creatinine clearance ≥30 ml/min (Cockcroft/Gault formula)
- Adequate blood counts: hemoglobin ≥8 g/dL, ANC ≥0.75 x10^9/L, platelets ≥50 x10^9/L
- Adequate coagulation: aPTT/PT/INR ≤1.5x ULN
- Willingness of women of childbearing potential and partners to use effective birth control during treatment and 1 month after
- Ability to take oral medication and follow study drug regimen
- Agreement to follow lifestyle considerations during study
- Able to understand and sign informed consent
You will not qualify if you...
- Diagnosis of Richter Transformation
- Documented central nervous system involvement
- Pregnancy or planning pregnancy during study or within 1 month after last dose; women must have negative pregnancy test
- Breastfeeding or planning to breastfeed during study or within 1 week after last dose
- Known active cytomegalovirus infection
- Active hepatitis B or hepatitis C infection as defined by positive tests or viral load
- HIV infection with detectable viral load or CD4 count <350; stable HIV patients on antiretroviral therapy ≥4 weeks prior eligible
- Significant gastrointestinal conditions affecting drug absorption (e.g., gastric bypass)
- Uncontrolled infections or active diseases posing risk per investigator judgment
- Stroke or intracranial hemorrhage within 6 months
- Hypertensive urgency or emergency
- Significant cardiovascular diseases including unstable angina, low heart function (LVEF ≤40%), uncontrolled arrhythmias, severe heart failure, recent myocardial infarction, or prolonged QT interval
- Allergy to pirtobrutinib or excipients
- History of bleeding disorders like von Willebrand disease or hemophilia
- Receipt of live vaccine within 28 days before first dose; killed vaccines allowed
- Use of therapeutic anticoagulation with warfarin or vitamin K antagonists; direct oral anticoagulants allowed
- Primary immunodeficiency or recent systemic immunosuppressive therapy
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapies
- Active uncontrolled autoimmune cytopenia requiring new or increased therapy within 4 weeks
- Active second cancer unless in remission with life expectancy >2 years
- Incomplete recovery from major surgery or ongoing complications
- Psychiatric or substance abuse disorders interfering with study participation
- Any condition or therapy that may interfere with study results or full participation as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NIH Clinical Center Office of Patient Recruitment (OPR)
CONTACT
L
Laura S Samples, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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