Pirtobrutinib for Elderly Patients with Chronic Lymphocytic Leukemia
This study is looking at how well a medicine called pirtobrutinib works in older patients (75 years and above) who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Pirtobrutinib is a type of targeted therapy that works by blocking a protein called BTK, which helps cancer cells grow. Other BTK inhibitors are already used for CLL, but sometimes they stop working. This study wants to see if pirtobrutinib can be a good option for elderly patients who haven't had other treatments for their CLL. Researchers will measure how many patients stop treatment and how many respond to pirtobrutinib after about a year. This study plans to enroll 50 patients, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 participants.
- What's involved
- You would take pirtobrutinib by mouth once a day. You would also have CT scans, blood tests, and bone marrow biopsies and aspirations throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would be followed up within 7-30 days and then every 6 months for up to 8 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07685717
Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia
Recruiting
PHASE2Ages 75+InterventionalTreatmentJennifer WoyachInvestigator-initiated
~50 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed TomographyElectronic Health Record ReviewPirtobrutinib
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of treatment discontinuation
Measured over Up to 12 cycles (Cycle length = 28 days)
+1 more outcome measured
Conditions
NCT07685717
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ohio State University Comprehensive Cancer Center
Columbus, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jennifer A Woyach, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
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Eligibility criteria
Inclusion
Men and women ≥ 75 years of age
Diagnosis of CLL/small lymphocytic lymphoma (SLL) meeting criteria established in the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines
Must be treatment-naive: Received no prior chemotherapy, immunotherapy, or targeted therapy for the treatment of CLL, with the exceptions of palliative loco-regional radiotherapy, rituximab for autoimmune conditions, or corticosteroids for symptoms control. For radiation, broad field radiation (≥ 30% of bone marrow or whole brain radiotherapy) must be completed 14 days before study enrollment; palliative limited field radiation must be completed 7 days prior to study enrollment. For rituximab, washout of 2 weeks is required prior to study enrollment
Must require treatment according to 2018 iwCLL guidelines
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN with documented liver involvement and/or Gilbert's syndrome
Creatinine clearance ≥ 30 mL/minute using Cockcroft-Gault formula
Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin time (PT) or (international normalized ratio \[INR\]) not greater than 2.0 × ULN
Absolute neutrophil count (ANC) ≥ 0.75 x 10\^9 (on or within 7 days of cycle 1 day 1 \[C1D1\] before treatment); the patient may enroll below threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis. Granulocyte colony-stimulating factor (GCSF) support is allowed
Platelet count ≥ 30 x 10\^9 not requiring transfusion support (on or within 7 days of C1D1 before treatment); the patient may enroll below this threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis
Hemoglobin ≥ 6 mg/dL not requiring transfusion support or growth factors (on or within 7 days of C1D1 before treatment); the patient may enroll below this threshold if there is documented bone marrow involvement of CLL considered to impair hematopoiesis
If patients require transfusion support due to bone marrow involvement of CLL, they must be responsive to transfusion support
Male patients are sexually active with a woman of childbearing potential must use highly effective methods of contraception during treatment
The patient is able to take oral medications
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information
Exclusion
Active Richter's transformation (i.e. within 6 months of active therapy, or requiring treatment for Richter's transformation)
Malabsorption syndrome or inability to absorb pirtobrutinib
Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, those with uncontrolled arrhythmia, and those patients who experienced an myocardial infarction (MI) within 3 months of screening or acute coronary syndrome within 2 months of screening are not eligible
Documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% in the 12 months prior to randomization
Prolongation of QT interval corrected for heart rate (QTcF) \> 470 msec
Major surgical procedure within 28 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug
Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)
History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug
Patients who have tested positive for human immunodeficiency virus (HIV) are excluded due to risk of opportunistic infections with both HIV and Bruton Tyrosine Kinase (BTK)-inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment
Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:
Hepatitis B virus (HBV):
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 starting study therapy
Patients who are HBV deoxyribonucleic acid (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
Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible
Evidence of other clinically significant uncontrolled condition(s) including but not limited to: uncontrolled systemic infection, or other clinically significant active disease process which in the opinion of the investigator may pose a risk for patient participation. Screening for chronic conditions is not required
Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
Active second malignancy unless in remission and with life expectancy \> 2 years
Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists
Vaccination with live vaccines 28 days prior to registration for study screening
Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components
What this trial measures
- Rate of treatment discontinuationUp to 12 cycles (Cycle length = 28 days)
Will be calculated among all evaluable patients. The rates will be provided together with 95% exact confidence intervals.
- Overall response rateUp to 12 cycles (Cycle length = 28 days)
Will be determined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL). Will be calculated among all evaluable patients. The rates will be provided together with 95% exact confidence intervals.