A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321) (BRUIN-MCL-321)

  • End date
    Apr 22, 2025
  • participants needed
  • sponsor
    Loxo Oncology, Inc.
Updated on 22 October 2022
measurable disease
neutrophil count
btk inhibitor


This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.


This is a Phase 3 global, randomized, open-label study comparing pirtobrutinib (Arm A) to investigator's choice of ibrutinib, acalabrutinib or zanubrutinib (Arm B) in MCL patients who have received 1 or more lines of therapy and are BTK inhibitor naïve.

Condition Lymphoma, Mantle-Cell
Treatment Ibrutinib, acalabrutinib, Zanubrutinib, LOXO-305, Pirtobrutinib
Clinical Study IdentifierNCT04662255
SponsorLoxo Oncology, Inc.
Last Modified on22 October 2022


Yes No Not Sure

Inclusion Criteria

Confirmed MCL diagnosis
Previously treated with at least one prior line of systemic therapy for MCL
Measurable disease per Lugano criteria
Eastern Cooperative Oncology Group (ECOG) 0-2
Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
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

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 2/3 consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs
Known HIV infection or active HBV, HCV, or CMV infections
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) 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 drug treatment
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Vaccination with live vaccine within 28 days prior to randomization
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