A Phase 3 Study of LOXO-305 in Patients with Mantle Cell Lymphoma
- Conditions
- Mantle Cell Lymphoma
- Registration Number
- JPRN-jRCT2021210026
- Lead Sponsor
- Ito Rodrigo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 22
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 x 109/L): independent of growth factor support within 7 days of Screening assessment
- Hemoglobin >= 8 g/dL: independent of transfusions, and of growth factor support within 7 days of Screening assessment
- Platelets >= 50 x 109/L: independent of transfusions, and of growth factor support within 7 days of Screening assessment
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method