Actively Recruiting
Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Led by M.D. Anderson Cancer Center · Updated on 2025-11-06
40
Participants Needed
1
Research Sites
411 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.
CONDITIONS
Official Title
Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older.
- Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma according to 2018 iwCLL criteria.
- Previously treated CLL requiring therapy based on 2018 iwCLL criteria.
- Able to take oral medications.
- Willing and able to provide signed informed consent.
- Prior or ongoing covalent BTK inhibitor therapy allowed but not required.
- Prior or ongoing BCL2 inhibitor therapy for at least six months allowed but not required; prior combination therapy with BTKi, BCL2i, and anti-CD20 antibody allowed if completed at least six months prior.
- Participants with prior venetoclax therapy must have achieved at least a partial response.
- Required washout periods before starting study treatment for targeted agents, investigational agents, antibodies, chemotherapy, and radiation therapy as specified.
- Prior treatment-related adverse events must have recovered to Grade 1 or less, except alopecia and Grade 2 peripheral neuropathy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate kidney, liver, bone marrow, and coagulation function as defined by specific laboratory values.
- Women of childbearing potential must have negative pregnancy tests and agree to use effective contraception during and after treatment; men with partners of childbearing potential must also use contraception.
You will not qualify if you...
- Disease progression while on venetoclax treatment.
- History or current diagnosis of Richter's syndrome.
- Known allergy to any study drugs or their components.
- Known or suspected central nervous system involvement by CLL/SLL.
- History of bleeding disorders or major bleeding events on prior BTK inhibitor treatment.
- Stroke or brain hemorrhage within 6 months before enrollment.
- Need for therapeutic anticoagulation with warfarin or similar agents.
- Major surgery within 4 weeks before starting study treatment.
- Significant medical disorders that could affect participation or study results.
- Recent stem cell transplant or CAR-T therapy within 60 days or ongoing complications from these treatments.
- Active uncontrolled autoimmune blood disorders requiring recent treatment changes.
- Severe arrhythmias or significant cardiovascular disease as defined.
- Prolonged QT interval on EKG above specified limits.
- Active hepatitis B or C infection.
- Other uncontrolled infections or active diseases posing risk.
- Known HIV infection or positive HIV test at screening.
- Active cytomegalovirus infection.
- Live vaccine received within 28 days before enrollment.
- Significant gastrointestinal conditions affecting drug absorption.
- Active malignancies other than certain skin or cervical/breast cancers unless in remission with expected survival over 2 years.
- Current use of strong CYP3A4 or P-gp inhibitors without sufficient washout.
- Pregnancy or breastfeeding during the study or within specified times after last dose.
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Alessandra Ferrajoli, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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