New combo aims to control CLL in just one year
NCT ID NCT06333262
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a one-year treatment plan using two drugs, pirtobrutinib and obinutuzumab, for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not had treatment before. The goal is to see if this fixed-duration therapy can control the disease effectively. About 60 participants will receive the combination over 12 cycles.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jul 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Brigham & Women's Hospital
RECRUITINGBoston, Massachusetts, 02215, United States
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Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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New England Cancer Specialists
RECRUITINGScarborough, Maine, 04074, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo aims to push CLL into deep remission
- Can a new BTK inhibitor outsmart resistance in CLL?
- Can a new pill outsmart Drug-Resistant leukemia?
- Can engineered immune cells beat tough B-Cell cancers?
- Can a targeted drug outperform chemo for a common blood cancer?
- Can a triple drug combo outsmart High-Risk CLL?