Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaPhase 2NCT07685717
Pirtobrutinib for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia
A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Jennifer Woyach at 1 site in United States.
Trial summary
This phase II trial studies how well pirtobrutinib works in treating elderly patients with chronic lymphocytic leukemia (CLL). Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib work by blocking the action of the BTK protein that signals cancer cells to multiply. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- What is being tested?
- Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Jennifer A. Woyach, MD, 614-293-3196, Jennifer.Woyach@osumc.edu
Jennifer A. Woyach, MD
About this study
Official title: A Phase 2 Trial of Single-Agent Pirtobrutinib for Elderly Patients With CLL
This phase II trial studies how well pirtobrutinib works in treating elderly patients with chronic lymphocytic leukemia (CLL). Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib work by blocking the action of the BTK protein that signals cancer cells to multiply. These are very effective, tolerable, and commonly used to treat people with CLL, but they may lead to drug resistance over time. Pirtobrutinib, also a BTK inhibitor, may work better in treating elderly patients with CLL.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate rate of discontinuation and overall response rate (ORR) of pirtobrutinib after 12 cycles in patients who are ≥ 75 with CLL.
SECONDARY OBJECTIVE:
- To assess the safety and efficacy of patients with CLL treated with pirtobrutinib.
EXPLORATORY OBJECTIVE:
- Assess the treatments effect on quality of life and on geriatric assessments.
OUTLINE:
Patients receive pirtobrutinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), blood sample collection, and bone marrow biopsy and aspiration throughout the study.
After completion of study treatment, patients are followed up within 7-30 days and then every 6 months for up to 8 years.
- Being tested
- Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Electronic Health Record Review
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow biopsy and aspiration
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow biopsy and aspiration
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Electronic Health Record ReviewOther
Ancillary studies
PirtobrutinibDrug
Also called 5-Amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2S)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide, BTK Inhibitor LOXO-305, Jaypirca, LOXO 305
Given PO
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pirtobrutinib) | Experimental | Patients receive pirtobrutinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, blood sample collection, and bone marrow biopsy and aspiration throughout the study. Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Other: Electronic Health Record Review; Drug: Pirtobrutinib; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of treatment discontinuation
Will be calculated among all evaluable patients. The rates will be provided together with 95% exact confidence intervals.
Measured: Up to 12 cycles (Cycle length = 28 days)
Overall response rate
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.
Measured: Up to 12 cycles (Cycle length = 28 days)
Secondary outcomes (5)
Progression-free survival
Will be estimated using the method of Kaplan-Meier.
Measured: From treatment start to the date of the corresponding event, assessed up to 5 years
Overall survival
Will be estimated using the method of Kaplan-Meier.
Measured: From treatment start to the date of the corresponding event, assessed up to 8 years after completion of study treatment
Duration of response
Will be estimated using the method of Kaplan-Meier.
Measured: From the date where the first response is achieved to the date of progression or death, assessed up to 8 years after completion of study treatment
Time to next treatment
Will be estimated using the method of Kaplan-Meier.
Measured: From treatment start to the date of the corresponding event, assessed up to 8 years after completion of study treatment
Incidence of adverse events (AEs)
Will determine rate of treatment related AEs, and proportion of patients who discontinue therapy due to AEs. The toxicity profile will be described through the summary of AE data. AE will be summarized by type and severity according to Common Terminology Criteria for Adverse Events, Version 5.0 for non-hematologic toxicity, and the iwCLL 2018 criteria for hematologic toxicity, with a focus on grade 3 or higher adverse events.
Measured: Up to 30 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start13 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Woyach
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Woyach, Ohio State University Comprehensive Cancer Center
- Investigators
- Jennifer A Woyach, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685717
- Sponsor's protocol ID
- OSU-25034
- Other IDs
- NCI-2026-04232, OSU-25034
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Single-Agent Pirtobrutinib for Elderly Patients With CLL
- ClinicalTrials.gov ID
- NCT07685717
- Acronym / sponsor ID
- OSU-25034
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jennifer WoyachUniversity, hospital or other
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well pirtobrutinib works in treating elderly patients with chronic lymphocytic leukemia (CLL). Bruton tyrosine kinase (BTK) inhibitors such as ibrutinib, acalabrutinib, and zanubrutinib work by blocking the action of the BTK protein that signals cancer cells to multiply. These are very effective, tolerable, and commonly used to treat people with CLL, but they may lead to drug resistance over time. Pirtobrutinib, also a BTK inhibitor, may work better in treating elderly patients with CLL.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate rate of discontinuation and overall response rate (ORR) of pirtobrutinib after 12 cycles in patients who are ≥ 75 with CLL.
SECONDARY OBJECTIVE:
- To assess the safety and efficacy of patients with CLL treated with pirtobrutinib.
EXPLORATORY OBJECTIVE:
- Assess the treatments effect on quality of life and on geriatric assessments.
OUTLINE:
Patients receive pirtobrutinib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT), blood sample collection, and bone marrow biopsy and aspiration throughout the study.
After completion of study treatment, patients are followed up within 7-30 days and then every 6 months for up to 8 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (pirtobrutinib) | Experimental | Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Procedure: Computed Tomography, Other: Electronic Health Record Review, Drug: Pirtobrutinib, Other: Questionnaire AdministrationPatients receive pirtobrutinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, blood sample collection, and bone marrow biopsy and aspiration throughout the study. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen CollectionUndergo collection of blood samples | Procedure or surgery | Treatment (pirtobrutinib) |
| Bone Marrow AspirationUndergo bone marrow biopsy and aspiration | Procedure or surgery | Treatment (pirtobrutinib) |
| Bone Marrow BiopsyAlso: Biopsy of Bone Marrow, Biopsy, Bone MarrowUndergo bone marrow biopsy and aspiration | Procedure or surgery | Treatment (pirtobrutinib) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (pirtobrutinib) |
| Electronic Health Record ReviewAncillary studies | Other | Treatment (pirtobrutinib) |
| PirtobrutinibAlso: 5-Amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-((2S)-1,1,1-trifluoropropan-2-yl)-1h-pyrazole-4-carboxamide, BTK Inhibitor LOXO-305, Jaypirca, LOXO 305Given PO | Drug | Treatment (pirtobrutinib) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (pirtobrutinib) |
Primary outcome
Rate of treatment discontinuation
Time frame: Up 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 rate
Time frame: Up 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.
5 secondary outcomes
Progression-free survival
Time frame: From treatment start to the date of the corresponding event, assessed up to 5 years
Overall survival
Time frame: From treatment start to the date of the corresponding event, assessed up to 8 years after completion of study treatment
Duration of response
Time frame: From the date where the first response is achieved to the date of progression or death, assessed up to 8 years after completion of study treatment
Time to next treatment
Time frame: From treatment start to the date of the corresponding event, assessed up to 8 years after completion of study treatment
Incidence of adverse events (AEs)
Time frame: Up to 30 days after completion of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Jennifer A Woyach, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biospecimen Collection, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, run by Jennifer Woyach at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (1-800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of treatment discontinuation (time frame: Up to 12 cycles (Cycle length = 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.