A Study to Investigate Sonrotoclax (BGB 11417) Plus Zanubrutinib (BGB 3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

JRCT ID: jRCT2051240174

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Previously untreated chronic lymphocytic leukemia
• Date of first enrollment: 15/10/2024
• Target sample size: 14
• Countries of recruitment: US,Japan,Canada,Japan,Brazil,Japan,Australia,Japan,New Zealand,Japan,Korea,Japan,China,Japan,France,Japan,Italy,Japan,Spain,Japan,UK,Japan,Turkey,Japan,Poland,Japan,Czech Republic,Japan,Netherlands,Japan,Sweden,Japan,Israel,Japan,Austria,Japan,Germany,Japan,Thailand,Japan,Malaysia,Japan,Ireland,Japan,Greece,Japan,Argentina,Japan,Mexico,Japan
• Study type: Interventional

Intervention(s)

Patients will be randomized in a 1:1 ratio to one of the following:
- Experimental: Sonrotoclax Plus Zanubrutinib
Participants will receive from start of Cycle 1 a standard dose of zanubrutinib once or twice daily orally and in combination with sonrotoclax starting from Cycle 4 onwards at increasing doses until target dose is reached and continuing until end of Cycle 15 (each cycle is 28 days)
- Active Comparator: Venetoclax Plus Obinutuzumab
Participants will receive obinutuzumab 100mg intravenously on Day 1 Cycle 1, followed by 900 mg on Day 2 Cycle 1 (or alternatively receive 1000 mg intravenously on Day 1), followed by 1000 mg on Days 8 and 15 of Cycle 1 and thereafter on Day 1 of Cycles 2 through 6 (each cycle is 28 days) in combination with venetoclax at increasing doses until target dose is reached from Day 22 Cycle 1 until end of Cycle 12 (each cycles is 28 days)

Outcome(s)

• Primary Outcome: PFS, defined as time from the date of randomization to the date of first confirmed disease progression as determined by IRC or death due to any cause, whichever occurs first.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Treatment-naive (TN) adults with confirmed diagnosis of CLL which requires treatment
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Measurable disease by Computer Tomography/Magnetic Resonance Imaging
- Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN
- Adequate renal function as defined as creatinine clearance >= 50 milliliters per minute

Exclude criteria

- Previous systemic treatment for CLL
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Known central nervous system involvement
- History of confirmed progressive multifocal leukoencephalopathy (PML)
Uncontrolled hypertension

Related Information

• Primary Sponsor: Tsumura Akari