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 (Jun 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
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Chronic Lymphocytic 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06967610 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior venetoclax, BTK inhibitor, BTK inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages