Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
- 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
- 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
- Current treatment with strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors.
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
- Vaccination with live vaccine within 28 days prior to randomization
This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (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.
Trial Phase Phase III
Trial Type Treatment
Loxo Oncology, Inc.
- Primary ID LOXO-BTK-20019
- Secondary IDs NCI-2021-05414
- Clinicaltrials.gov ID NCT04662255