Actively Recruiting
Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia
Led by Inhye Ahn · Updated on 2026-01-21
60
Participants Needed
4
Research Sites
427 weeks
Total Duration
On this page
Sponsors
I
Inhye Ahn
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma according to 2018 IWCLL guidelines
- Measurable disease with lymphocyte count > 5,000/µL, lymph nodes ≥ 1.5 cm on imaging, or bone marrow involvement ≥ 30%
- No prior systemic treatment for CLL or SLL
- Indication for treatment based on 2018 IWCLL guidelines
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 2 or less
- Adequate organ and bone marrow function as defined by study protocol
- Ability to take oral medications
- Willingness and ability to provide written informed consent
You will not qualify if you...
- Known or suspected Richter's transformation or central nervous system involvement
- History of bleeding disorders
- Stroke or intracranial hemorrhage within 6 months before starting study treatment
- Significant cardiovascular disease including uncontrolled arrhythmia, severe heart failure, or reduced left ventricular ejection fraction (< 40%) within past 12 months
- History of other cancers with life expectancy under 2 years
- Receiving other investigational agents
- Recent systemic immunosuppression within 28 days or prednisone over 20 mg daily within 7 days before study treatment
- Live vaccine within 4 weeks before starting treatment
- Major surgery within 4 weeks before starting treatment
- Current or recent infection requiring intravenous antibiotics at screening
- Positive HIV test or unknown HIV status without negative test at screening
- Active infections with human T cell leukemia virus, hepatitis B or C, or cytomegalovirus
- Pregnancy, breastfeeding, or planning to breastfeed during or within 6 months after treatment
- Active malabsorption syndrome or conditions affecting drug absorption
- Active uncontrolled autoimmune cytopenia
- Significant other co-morbid conditions or diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
New England Cancer Specialists
Scarborough, Maine, United States, 04074
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
H
Hang Phan, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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