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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 (Jun 2026). This Phase 2 trial studies multiple treatments for leukemia.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT05536349Data as of Jun 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

Treatments studied

Immunotherapy

Obinutuzumab

Targeted therapy

PirtobrutinibVenetoclax

Other

ValacyclovirAllopurinol

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.

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