OncoMatch/Clinical Trials/NCT05536349
Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)
Is NCT05536349 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for leukemia.
Treatment: Pirtobrutinib · Obinutuzumab · Venetoclax · Valacyclovir · Allopurinol — To learn if the combination of pirtobrutinib (also called LOXO-305), venetoclax, and obinutuzumab is safe and effective when given to patients with chronic lymphocytic leukemia (CLL) or Richter transformation (RT) who have not previously received treatment.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — for CLL
Previously untreated patients with RT must have received prior therapy for CLL
Cannot have received: anti-CD20 monoclonal antibody
Exception: for non-malignant indication, including for autoimmune phenomenon
Prior receipt of anti-CD20 monoclonal antibody therapy for non-malignant indication, including for autoimmune phenomenon
Cannot have received: systemic therapy
Prior receipt of systemic therapy for CLL/SLL
Cannot have received: BTK inhibitor
Exception: Patients who experienced a major bleeding event or grade ≥3 arrythmia on prior treatment with a BTK inhibitor
Patients who experienced a major bleeding event or grade ≥3 arrythmia on prior treatment with a BTK inhibitor
Cannot have received: stem cell transplant
Exception: within 60 days of first dose of study drugs
History of allogeneic or autologous stem cell transplant (SCT) within 60 days of first dose of study drugs
Cannot have received: CAR-T cell therapy
Exception: within 60 days of first dose of study drugs
chimeric antigen receptor-modified T cell (CAR-T) therapy within 60 days of first dose of study drugs
Cannot have received: immunoconjugated antibody
Exception: within 10 weeks prior to randomization
Immunoconjugated antibody treatment within 10 weeks prior to randomization
Lab requirements
Blood counts
Platelet count ≥50 x10^9/L and hemoglobin ≥ 8 g/dL (≥ 80 g/L), independent of transfusions within 7 days; Absolute neutrophil count ≥ 0.75 x 10^9/L, independent of growth factor support within 7 days
Kidney function
Creatinine clearance ≥ 50 ml/min (calculated using CKD-EPI formula)
Liver function
Total bilirubin ≤1.5 x ULN or ≤3 x ULN for patients with Gilbert's disease or documented disease involvement of liver; ALT and AST ≤3.0 x ULN, or ≤5.0 x ULN if documented disease involvement of liver
Adequate hepatic function; Adequate renal function; Adequate hematologic function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05536349 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CD20 monoclonal antibody, systemic therapy, 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 qualify