Pirtobrutinib and Obinutuzumab for Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
This study is testing a fixed-duration treatment of pirtobrutinib and obinutuzumab for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not yet received treatment. You would take pirtobrutinib by mouth daily for about one year, and also receive obinutuzumab intravenously (through a vein) for six months during that time. The main goal is to see how many people have a complete response (meaning no signs of cancer) after one year of treatment. The study plans to enroll up to 60 participants. The current status of the study is unclear.
- Study design
- This is an open-label, single-arm study, meaning everyone receives the same treatment and both you and the study team will know which drugs you are taking. Up to 60 participants will be enrolled.
- What's involved
- You would have screening for eligibility, study treatment visits, electrocardiograms, imaging like CT scans, blood tests, saliva tests, and possibly bone marrow or lymph node biopsies. The initial treatment lasts for about one year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to a total of 10 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06333262
Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia
Recruiting
PHASE2Ages 18+InterventionalTreatmentInhye AhnInvestigator-initiated
~60 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:PirtobrutinibObinutuzumab
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of complete response after initial therapy
Measured over 1 year since treatment initiation
Conditions
Where it's being run
4 sites across 2 statesMassachusetts3
Maine1
Study leadership
- Inhye E Ahn, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
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.
Eligibility criteria
Inclusion
Meet 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for the diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Presence of measurable disease (absolute lymphocyte count \> 5,000/µL, palpable or measurable lymph nodes ≥1.5cm on imaging, or bone marrow involvement of CLL ≥ 30%).
No prior systemic therapy for CLL or SLL.
Currently have an indication for treatment as defined by the following 2018 IWCLL guidelines
Age ≥ 18 years
Eastern Cooperative Oncology Group performance status ≤ 2
Adequate organ and bone marrow function as defined by the study protocol
Ability to take oral medications.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
Known or suspected Richter's transformation or known central nervous system involvement.
History of bleeding disorders
History of stroke or intracranial hemorrhage within 6 months of starting study therapy.
Significant cardiovascular disease such as uncontrolled arrhythmia, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction \< 40% by any methods in the 12 months prior to study therapy.
History of other malignancies with life expectancy of \< 2 years.
Receiving any other investigational agents.
Concurrent systemic immunosuppression \< 28 days of study therapy or administration of \> 20 mg of prednisone or equivalent daily \< 7 days of study therapy.
Vaccinated with live vaccine within 4 weeks of starting study therapy.
Major surgery within 4 weeks of starting study therapy.
Ongoing or recent infection requiring intravenous antimicrobials at time of screening. Prophylactic antibiotics are allowed if there is no evidence of active infection and the antibiotics is not included on the list of the prohibited medications.
Patients who have tested positive for HIV are excluded due to potential drug-drug interactions between anti-retroviral medications and pirtobrutinib and risk of opportunistic infections with both HIV and irreversible BTK inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result should be negative for enrollment.
Active human T cell leukemia virus infection or active hepatitis B or C virus infection
Known active cytomegalovirus infection
Pregnancy, lactation or plan to breastfeed during the study or within 6 months of the last dose of study treatment.
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug
Active uncontrolled auto-immune cytopenia.
Significant co-morbid condition or disease.
What this trial measures
- Rate of complete response after initial therapy1 year since treatment initiation
Defined by the 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines