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

Conditions

• CLL

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sonrotoclax — DRUG
  Administered orally
• Zanubrutinib — DRUG
  Administered orally
• Venetoclax — DRUG
  Administered orally
• Obinutuzumab — DRUG
  Administered intravenously

Study Details

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)

Key Dates

Start date

Nov 11, 2023

Status verified

May 2026

Primary completion

Feb 29, 2032

Completion

Dec 31, 2032

Study Design

Enrollment

652 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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)

Primary Outcome Measure

Cohort 1: Progression Free Survival (PFS） [ Time Frame: Up to approximately 9 years ]

Locations (40)

Find similar trials in Anchorage, AK

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