Patologia: Neoplasie ematologiche
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: II
Linee di trattamento: Prima linea
Criteri di inclusione:
- Previously untreated adult patient ≥ 18 years with a confirmed diagnosis of CLL.
- CLL requiring treatment as per pre-defined criteria.
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
- Measurable disease by CT/MRI.
- Adequate marrow function.
- Adequate liver function as indicated by aspartate aminotransferase (AST) alanine aminotransferase (ALT) and serum total bilirubin.
- Adequate renal function.
- Life expectancy > 6 months.
- Signed informed consent and able to comply with the study protocol in the investigator's judgment.
- Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 90 days after the last dose of study drug.
Criteri di esclusione:
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Known central nervous system involvement
- Received previous systemic treatment for CLL
- Clinically significant cardiovascular disease
- Severe or debilitating pulmonary disease
- History of prior malignancy
- Active fungal, bacterial, and/or viral infection requiring systemic therapy
- Positive HIV serology (HIVAb) status or serologic status reflecting active hepatitis B or C infection
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment
- History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention
- History of stroke or intracranial hemorrhage ≤ 6 months before the first dose of study treatment
- Unable to swallow capsules or tablets or diseases significantly affecting GI function
- Hypersensitivity to zanubrutinib, sonrotoclax, or any of its excipients
- Use of investigational agents within the last 4 weeks before screening
- Pregnant and lactating females
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trattamento sperimentale:
Sonrotoclax (BGB-11417)+ Zanubrutinib (BGB-3111)
Trattamento di controllo:
Zanubrutinib (BGB-3111)
ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS
Email: ematologia@asst-spedalicivili.it
A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
Riferimento: Prof. Roberto Marasca
Email: roberto.marasca@unimore.it
AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
SOD Ematologia
AO “V. Cervello”
Via Trabucco 180 - 90146 Palermo - PA
UOC Oncoematologia
Telefono: 0916802642
Numero di iscrizione a registro: 2024-513970-23-00
Data di inserimento: 15.05.2025
BeiGene
Riferimento: Dr. Info non applicabile
Telefono: 00000
Email: na@na.it
Localita: na