Patologia: Linfomi, Neoplasie ematologiche
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: Sì
Fase di studio: III
Linee di trattamento: Seconda linea
Criteri di inclusione:
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
- Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Estimated creatinine clearance ≥30 milliliters per minute (mL/min).
Criteri di esclusione:
- Known or suspected Richter's transformation at any time preceding enrollment
- Prior therapy with a non-covalent (reversible) BTK inhibitor
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
- Prior therapy with venetoclax
- Central nervous system (CNS) involvement
- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
- Active hepatitis B or hepatitis C
- Known active cytomegalovirus (CMV) infection
- Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
- Significant cardiovascular disease
- Vaccination with a live vaccine within 28 days prior to randomization
- Patients with the following hypersensitivity:
- Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
- Prior significant hypersensitivity to rituximab
- Known allergy to allopurinol and inability to take uric acid lowering agent.
Trattamento sperimentale:
Loxo-305 Pirtobrutinib + Venetoclax and Rituximab
Trattamento di controllo:
Venetoclax and Rituximab
Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Riferimento: Prof. Pierluigi Zinzani
Email: pierluigi.zinzani@unibo.it
Azienda Ospedaliero Universitaria di Ferrara
Via Aldo Moro 8 - 44124 Cona - FE
Ospedale Sant'Anna
Riferimento: Prof. Antonio Cuneo
Telefono: 0532236978
Email: sse@unife.it
IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC
Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Riferimento: Prof. Paolo Ghia
Email: segreteriallc@hsr.it
A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
Riferimento: Prof. Roberto Marasca
Telefono: 0594224315
Email: roberto.marasca@unimore.it
A.O.U. Maggiore della Carità
Corso Mazzini 18 - 28100 Novara - NO
AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
A.O. Pugliese-Ciaccio
Viale Pio X - 88100 Catanzaro - CZ
Numero di iscrizione a registro: 2021-000043-49
Data di inserimento: 01.08.2022
Data di aggiornamento: 11.11.2022
Loxo Oncology, Inc.
Fondazione Policlinico Universitario Agostino Gemelli, Roma
Riferimento: Dr. Info non disponibile
Telefono: 00000
Email: nd@nd.it
Localita: Roma