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

Recruiting now · Early Phase 1

Conditions studied: Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)

In brief

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 facts

Study ID: NCT07428707
Run by: National Heart, Lung, and Blood Institute (NHLBI)
People needed: 30
Starts: 2026-03-11
Expected to finish: 2030-03-01
Last updated by the study team: 2026-07-21

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Diagnosis of Richter Transformation
Documented CNS involvement
Pregnancy or plan to become pregnant during the study or within 1 month of the last dose of study treatment. WOCBP must have a negative serum pregnancy test.
Lactation or plan to breastfeed during the study or within 1 week of the last dose of study treatment.
Known active cytomegalovirus (CMV) infections. Unknown or negative status are eligible.
Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:
Patients with positive hepatitis B surface antigen (HBsAg) are excluded.
Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before randomization.
Patients who are HBV DNA PCR positive will be excluded.
Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before randomization. Patients who are hepatitis C RNA positive will be excluded.
Patients who have tested positive for Human Immunodeficiency Virus (HIV) and have a detectable viral load and/or a CD4 count <350 are excluded due to risk of opportunistic infections with both HIV and BTK inhibitors. Eligible patients with HIV must be stable on antiretroviral therapy >=4 weeks prior to study entry. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment.
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of the study drug. (e.g., gastric bypass surgery, gastrectomy).
Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for patient participation. Screening for chronic conditions is not required.
Stroke or intracranial hemorrhage within 6 months of screening
Hypertensive urgency or emergency
Active, clinically significant cardiovascular disease including:
Unstable angina or acute coronary syndrome within the past 2 months prior to screening
Documentation of LVEF by any method of <= 40% in the 12 months prior to screening
Uncontrolled or symptomatic arrhythmias
Class 3 or 4 congestive heart failure as defined by New York Heart Association Functional Classification
Myocardial infarction, unstable angina or acute coronary syndrome within 3 months of screening.
Prolongation of the QT interval corrected for heart rate (QTcF) > 470 msec. QTcF is calculated using Fridericia s Formula (QTcF): QTcF=QT/(RR\^0.33)
Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator s discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.
Correction for underlying bundle branch block (BBB) allowed.
Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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