Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

BeiGene

Status and phase: Enrolling; Phase 3

Conditions: CLL

Treatments: Drug: Zanubrutinib; Drug: Sonrotoclax; Drug: Venetoclax; Drug: Obinutuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06073821

BGB-11417-301

Details and patient eligibility

About

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

Full description

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong participant life and control disease-related symptoms.

In this study, participants with CLL, without prior treatment will receive either venetoclax plus obinutuzumab combination treatment that is considered a standard first line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating CLL.

The main purpose of this study is to compare the duration the participants live without the CLL getting worse between participants who received venetoclax plus obinutuzumab versus sonrotoclax plus zanubrutinib. Approximately 640 participants will be included in this study around the world. Participants will have equal chance to be allocated to receive either of the treatment combinations.

Enrollment: 640 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment-naïve (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

Exclusion 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

Note: Other protocol defined criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

Sonrotoclax Plus Zanubrutinib

Experimental group

Description:

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)

Treatment:

Drug: Sonrotoclax

Drug: Zanubrutinib

Venetoclax Plus Obinutuzumab

Active Comparator group

Description:

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)

Treatment:

Drug: Obinutuzumab

Drug: Venetoclax