Phase 3  | 
 | Investigational Drug

BRUIN MCL-321; NCT04662255


BTK Inhibitor

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Investigator’s Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor-Naïve Mantle Cell Lymphoma*

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Key Inclusion Criteria
  • Confirmed mantle cell lymphoma (MCL) diagnosis that has been previously treated with at least one prior line of systemic therapy
  • Measurable disease per Lugano criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Absolute neutrophil count ≥0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
  • Hemoglobin ≥8 g/dL and platelets ≥50 × 109/L not requiring transfusion support or growth factors within 7 days of screening
  • AST and ALT ≤3.0 x upper limit of normal (ULN); total bilirubin ≤1.5 x ULN
  • Creatinine clearance of ≥30 mL/min according to Cockcroft-Gault formula
Key Exclusion Criteria
  • Prior treatment with an approved or investigational BTK inhibitor
  • History of bleeding diathesis
  • History of stroke or intracranial hemorrhage within 6 months of randomization
  • History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60 days of randomization
  • Clinically significant cardiovascular disease
  • Prolonged QT interval corrected using Fridericia's formula (QTcF) >470 ms on two out of three consecutive ECGs, and mean QTcF >470 ms on all three ECGs
  • Known HIV infection or active HBV, HCV, or CMV infections
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption
  • Ongoing chronic treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, which cannot be stopped within 3-5 half-lives of the CYP3A inhibitor therapy prior to start of study treatment
  • Patients requiring therapeutic anticoagulation with warfarin or another vitamin K antagonist
  • Vaccination with live vaccine within 28 days prior to randomization
This clinical trial is being conducted globally.
Pirtobrutinib is administered 200 mg PO QD until therapy discontinuation. 
Ibrutinib is administered 560 mg PO QD. 
Acalabrutinib is administered 100 mg PO BID.
Zanubrutinib is administered 160 mg PO BID or 320 mg PO QD. 
Contact the Loxo Oncology at Lilly Clinical Trial Team

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The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.