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New treatment option for Chronic Lymphocytic Leukemia
Official title Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia
ClinicalTrials.gov ID: NCT06333262
What this study is testing
What is Pirtobrutinib?
Pirtobrutinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Meet 2018 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines for the diagnosis of chronic lymphocytic leukemia (CLL) or small...
- Presence of measurable disease (absolute lymphocyte count \> 5,000/µL, palpable or measurable lymph nodes ≥1.5cm on imaging, or bone marrow...
- 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
You likely can't join if
- 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...
- History of other malignancies with life expectancy of \< 2 years.
- Receiving any other investigational agents.
See the full eligibility 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
- 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 \<...
- History of other malignancies with life expectancy of \< 2 years.
- Receiving any other investigational agents.
- Concurrent systemic immunosuppression \ 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scarborough, Maine, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scarborough, Maine, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.