BGB-11417-204 - A Multicenter, Open-Label, Phase 2 Study to Investigate the Efficacy and Safety of Sonrotoclax Combined With Zanubrutinib Compared With Zanubrutinib Monotherapy in Adult Patients With Previously Untreated Chronic Lymphocytic Leukemia

Studio Clinico

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)

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-513970-23-00

Data di inserimento: 15.05.2025

Promotore

BeiGene

Principal Investigator ITALIA

Riferimento: Dr. Info non applicabile

Telefono: 00000

Email: na@na.it

Localita: na