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Study identifier: NCT07428707 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Immune Profiling of CLL/SLL Treated With First-Line Pirtobrutinib

Condition: Chronic Lymphocytic Leukemia (CLL) · Small Lymphocytic Lymphoma (SLL)  ·  Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

PhaseEARLY_Phase 1
Planned participants30
Who can joinAll sexes, 18 Years to 100 Years
Healthy volunteersNo

About this study

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 th…

This description comes directly from the study's public registry record.

Talk to the study team

NIH Clinical Center Office of Patient Recruitment (OPR)  ·  (800) 411-1222  ·  ccopr@nih.gov

Laura S Samples, M.D.  ·  (301) 827-1203  ·  laura.samples@nih.gov

Always discuss trial participation with your own doctor first.

Locations (1)

National Institutes of Health Clinical CenterBethesda, Maryland, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07428707