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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT07428707
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    Pirtobrutinib will be administered orally at a dose of 200 mg once daily in 28-day cycles

Study Details

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....

Key Dates

Start date
Mar 11, 2026
Status verified
Jun 2026
Primary completion
Feb 1, 2030
Completion
Mar 1, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Pirtobrutinib
    Pirtobrutinib will be administered orally at a dose of 200 mg once daily in 28-day cycles, and participants will continue treatment until disease progression, unacceptable toxicity, or meeting other discontinuation criteria

Primary Outcome Measure

Immune cell composition of lymph nodes at baseline and on pirtobrutinib [ Time Frame: Baseline, Cycle 1 Day 7 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By research site
National Institutes of Health Clinical Center· Bethesda, MD

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