Back to search results

Pirtobrutinib for Untreated CLL/SLL

This study is looking at pirtobrutinib, a drug already approved for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) after previous treatments. Researchers want to see how pirtobrutinib affects the immune system when given as the first treatment for CLL or SLL. You may be able to join if you are 18 or older and have been diagnosed with CLL or SLL but haven't started other treatments yet. The main goal is to understand changes in immune cells in your lymph nodes after taking pirtobrutinib. The study is currently unclear on its recruitment status and plans to enroll 30 participants.

Study design
This is an interventional pilot study, meaning all 30 participants will receive pirtobrutinib. It is not specified if it's randomized or blinded.
What's involved
You will take pirtobrutinib by mouth once daily in 28-day cycles until your disease progresses or side effects become too much. You will have physical exams, blood tests, imaging scans, heart function tests, and immune cell analysis from your lymph nodes and blood at the beginning and during treatment.
Compensation
Not stated in the trial record.
Follow-up
Immune cell composition will be measured at baseline and on pirtobrutinib (at Baseline, Cycle 1 Day 7).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07428707

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalBasic science
National Heart, Lung, and Blood Institute (NHLBI)
~30 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Pirtobrutinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Immune cell composition of lymph nodes at baseline and on pirtobrutinib
Measured over Baseline, Cycle 1 Day 7

Conditions

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

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Laura S Samples, M.D. · PRINCIPAL_INVESTIGATOR · National Heart, Lung, and Blood Institute (NHLBI)

Who to contact

NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
(800) 411-1222
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

System: Hepatic
Laboratory Value: ALT or AST: \<= 3 x the ULN or \<= 5 x ULN with documented liver involvement
Laboratory Value: Total bilirubin: \<= 1.5 x ULN or \<= 3 x ULN with documented liver involvement and/or Gilbert s Disease
System: Renal
Laboratory Value: Serum creatinine: Calculated creatinine clearance \>= 30 ml/min according to Cockcroft/Gault Formula: \[(140-age) x body weight (kg) x 0.85 (if female)\]/ \[serum creatinine (mg/dL) x 72\]
System: Hematologic
Laboratory Value: Hemoglobin: \>= 8 g/dL (\>= 80 g/L)
Laboratory Value: ANC: \>= 0.75 x 10\^9/L
Laboratory Value: Platelets: \>= 50 x 10\^9/L

Exclusion

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)

What this trial measures

  • Immune cell composition of lymph nodes at baseline and on pirtobrutinibBaseline, Cycle 1 Day 7

    Immune cell composition estimated by deconvolution of bulk RNA sequencing (RNA-seq) of lymph node (LN) at baseline and on C1D7