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
AO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL
Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Riferimento: Prof. Pierluigi Zinzani
Telefono: 0512143680
Email: pierluigi.zinzani@unibo.it
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE
Riferimento: Prof. Roberto Lemoli
Telefono: 0103358978
Email: roberto.lemoli@unige.it
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Riferimento: Dr. Andrés Ferreri
Telefono: 0226437649
Email: ferreri.andres@hsr.it
IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV
Ospedale S. Maria delle Croci, Ravenna
Viale Randi 5 - 48121 Ravenna - RA
Riferimento: Dr.ssa Monica Tani
Telefono: 0544285722
Email: monica.tani@auslromagna.it
AUSL/IRCCS di Reggio Emilia
Viale Risorgimento 80 - 42123 Reggio nell'Emilia - RE
Arcispedale Santa Maria Nuova
Ospedale di Circolo Fondazione Macchi
Viale Luigi Borri 57 - 21100 Varese - VA
Istituto Tumori “Giovanni Paolo II” IRCCS
Viale Orazio Flacco 65 - 70124 Bari - BA
AO Papardo
Contrada Papardo - 98158 Messina - ME
AO “V. Cervello”
Via Trabucco 180 - 90146 Palermo - PA
IRCCS CROB
Via Padre Pio 1 - 85028 Rionero In Vulture - PZ
Riferimento: Dr. Giuseppe Pietrantuono
Telefono: 0972726685
Email: giuseppe.pietrantuono@crob.it
Numero di iscrizione a registro: 2020-004553-72
Data di inserimento: 22.07.2022
Data di aggiornamento: 14.11.2022
Loxo Oncology, Inc.
Policlinico Universitario Sant'Orsola Malpighi, Bologna
Riferimento: Prof. Pierluigi Zinzani
Telefono: 0512143680
Email: pierluigi.zinzani@unibo.it
Localita: Bologna