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 (May 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
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
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 →
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