J2N-OX-JZNM - 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)

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: III

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- 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.

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Pirtobrutinib (Loxo 305)

Trattamento di controllo: 

Standard of Care, any approved BTK inhibitor for MCL

Centri partecipanti

Nord Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-004553-72

Data di inserimento: 22.07.2022

Data di aggiornamento: 14.11.2022

Promotore

Loxo Oncology, Inc.

Principal Investigator ITALIA

Policlinico Universitario Sant'Orsola Malpighi, Bologna

Riferimento: Prof. Pierluigi Zinzani

Telefono: 0512143680

Email: pierluigi.zinzani@unibo.it

Localita: Bologna