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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.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT05536349Data as of May 2026

Treatment: Pirtobrutinib · Obinutuzumab · Venetoclax · Valacyclovir · AllopurinolTo 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.

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Extracted 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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