Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia
A Phase 2 Study of Fixed Duration Therapy With Pirtobrutinib and Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia (POP)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws, CT scans, Biopsies, Heart tracing (ECG)
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The research study procedures include screening for eligibility, study treatment visits, electrocardiograms, imaging (e.g. computerized tomography or CT scans), blood tests, saliva tests, bone marrow biopsies, and/or lymph node biopsies (if feasible)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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.
Study sites (4)
MA
- Beth Israel Deaconess Medical Center · Boston, MA 02215Jon Arnason, MD · Study contactJon Arnason, MD · Principal investigatorMore trials in Boston
- Brigham & Women's Hospital · Boston, MA 02215Inhye Ahn · Study contactInhye Ahn, MD · Principal investigatorMore trials in Boston
- Dana-Farber Cancer Institute · Boston, MA 02215Megan Forsyth · Study contact · 857-215-1405 · megan_forsyth@dfci.harvard.eduInhye Ahn, MD · Principal investigatorMore trials in Boston
ME
- New England Cancer Specialists · Scarborough, ME 04074Cindy Taylor · Study contact · 207-303-3420 · tayloc@newecs.orgJohn P Winters, III, MD · Principal investigatorMore trials in Scarborough