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).

Recruiting now · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia (SLL)

In brief

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.

Key facts

Study ID: NCT06967610
Run by: M.D. Anderson Cancer Center
People needed: 40
Starts: 2025-07-15
Expected to finish: 2033-06-01
Last updated by the study team: 2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Participants who experienced progression of disease according to 2018 iwCLL criteria while on venetoclax will be excluded.
Patient with prior history of Richter's syndrome or current Richter's Syndrome.
Participants with known hypersensitivity to any of the excipients of pirtobrutinib, venetoclax,obinutuzumab or to any intended study medications.
Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
History of bleeding diathesis.
Participants who experienced a major bleeding event on a prior BTK inhibitor.• NOTE: Major bleeding is defined as bleeding having one or more of the following features: life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2 g/dL; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome).
History of stroke or intracranial hemorrhage within 6 months of enrollment.
Participants requiring therapeutic anticoagulation with warfarin or another vitamin K antagonists.
Major surgery within 4 weeks of planned start of study therapy.
A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disorder, that, in the opinion of the Investigator, would adversely affect the participant's participation in this study or interpretation of study outcomes.
History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified Tcell (CAR-T) therapy within 60 days of enrollment or presence of any of the following, regardless of prior SCT and/or CAR-T therapy timing:
active graft versus host disease (GVHD);
cytopenia from incomplete blood cell count recovery post-transplant;
need for anti-cytokine therapy for toxicity from CAR-T therapy; residual symptoms of neurotoxicity > Grade 1 from CAR-T therapy;
ongoing immunosuppressive therapy (> 20 mg prednisone or equivalent daily).
Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.
Participants who experienced grade >3 arrhythmia on prior treatment with BTK inhibitor.
Significant cardiovascular disease, defined as any of the following:
Unstable angina or acute coronary syndrome within the past 2 months.
History of myocardial infarction within 6 months prior to planned start of study treatment.
Documented left ventricular ejection fraction (LVEF) by any method of ≤ 45% in the 12 months prior to planned start of study treatment.
≥ Grade 3 New York Heart Association (NYHA) functional classification system of heart failure.
uncontrolled or symptomatic arrhythmias
Prolongation of the QT interval corrected (QTc - see Appendix 3) for heart rate using Fredericia's Formula (QTcF) > 470 msec on an EKG during screening.
QTcF is calculated using Fredericia's Formula (QTcF = QT/(RR\^0.33)

Where it is running

MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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