Lymphoma, Mantle-Cell
Conditions
Interventions
Drug: Pirtobrutinib
Oral
Other Names:
LOXO-305
LY3527727
Drug: Ibrutinib
Oral
Other Name: Imbruvica
Drug: Acalabrutinib
Oral
Other Name: Calquence
Drug: Zanubrutinib
Oral
Other Name: Brukinsa
[Study
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 = 30 mL/min according to Cockcroft/Gault Formula
Exclusion criteria
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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to investigator choice of covalent BTK inhibitor monotherapy (Arm B) in patients with previously treated mantle cell lymphoma (MCL) [ Time Frame: Up to approximately 24 months ] Assessed per Lugano criteria | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Portugal, Republic of Korea, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K.
IQVIA Services Japan G.K.
Outcome results
None listed