OncoMatch/Clinical Trials/NCT06967610
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).
Is NCT06967610 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pirtobrutinib and Venetoclax for chronic lymphocytic leukemia.
Treatment: Pirtobrutinib · Venetoclax · Obinutuzumab — To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Acute Lymphoblastic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor — allowed
Prior or ongoing therapy with covalent BTKi is allowed, but not required
Must have received: BCL2 inhibitor — allowed
Prior or ongoing therapy (at least for six months) with BCL2i is allowed, but not required
Must have received: BTK inhibitor, BCL2 inhibitor, anti-CD20 monoclonal antibody (combination) — allowed
Prior therapy with combined BTKi and BCL2i or triplet BTKi, BCL2 and anti-CD20 mAb is allowed, but Participants need to be at least six months after completion of combination therapy
Cannot have received: venetoclax (venetoclax)
Exception: Participants with history of prior venetoclax therapy should have achieved at least a partial response or better while receiving venetoclax therapy
Participants who experienced progression of disease according to 2018 iwCLL criteria while on venetoclax will be excluded
Cannot have received: BTK inhibitor
Exception: Participants who experienced a major bleeding event on a prior BTK inhibitor
Participants who experienced a major bleeding event on a prior BTK inhibitor
Cannot have received: BTK inhibitor
Exception: Participants who experienced grade >3 arrhythmia on prior treatment with BTK inhibitor
Participants who experienced grade >3 arrhythmia on prior treatment with BTK inhibitor
Cannot have received: allogeneic or autologous stem cell transplant (SCT), CAR-T cell therapy
Exception: within 60 days of enrollment or presence of active 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)
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
Lab requirements
Blood counts
Platelet count of ≥50,000/μl, with no platelet transfusion in prior 2 weeks; ANC ≥750/μl in the absence of growth factor support within 7 days of screening assessment; Hemoglobin ≥8g/dL, independent of transfusions within 7 days of screening assessment
Kidney function
Serum creatinine clearance of ≥30ml/min (calculated or measured)
Liver function
Serum bilirubin ≤1.5 x ULN or ≤3 x ULN for Participants with Gilbert's disease or disease involvement by CLL/SLL; ALT and AST ≤3.0 x ULN, unless clearly due to documented disease involvement, in which case ALT and AST ≤5.0 x ULN
Cardiac function
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 (QTcF) for heart rate using Fredericia's Formula (QTcF) > 470 msec on an EKG during screening
Participants must have adequate renal and hepatic function: Serum bilirubin ≤1.5 x ULN or ≤3 x ULN for Participants with Gilbert's disease or disease involvement by CLL/SLL. Serum creatinine clearance of ≥30ml/min (calculated or measured). ALT and AST ≤3.0 x ULN, unless clearly due to documented disease involvement, in which case ALT and AST ≤5.0 x ULN. Adequate bone marrow function: Platelet count of ≥50,000/μl, with no platelet transfusion in prior 2 weeks. ANC ≥750/μl in the absence of growth factor support within 7 days of screening assessment. Hemoglobin ≥8g/dL, independent of transfusions within 7 days of screening assessment. Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time and prothrombin time (PT) or international normalized ratio (INR) not greater than 1.5 x ULN. 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 (QTcF) for heart rate using Fredericia's Formula (QTcF) > 470 msec on an EKG during screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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