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Monoclonal Antibodies

Sonrotoclax Plus Zanubrutinib for Chronic Lymphocytic Leukemia

Phase 3
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 9 years
Awards & highlights

Study Summary

This trial aims to compare the effectiveness of two different treatments for chronic lymphocytic leukemia (CLL): sonrotoclax plus zanubrutinib, and venetoclax plus ob

Who is the study for?
This trial is for adults who haven't been treated for chronic lymphocytic leukemia (CLL) yet. They should be able to perform daily activities with ease or have only slight limitations (ECOG score 0-2), have measurable disease visible on scans, and their liver and kidneys must work well enough based on specific blood tests.Check my eligibility
What is being tested?
The study aims to see which treatment works better for CLL: Sonrotoclax with Zanubrutinib or Venetoclax with Obinutuzumab. Participants will receive one of these combinations to compare their effectiveness in treating the condition.See study design
What are the potential side effects?
Potential side effects may include nausea, fatigue, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, liver function changes, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My kidneys work well enough (creatinine clearance ≥ 50 mL/min).
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My liver tests are within the normal range set by the hospital.
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I have chronic lymphocytic leukemia needing treatment and haven't received any.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 9 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
CRR by Investigator Assessment
Complete Response Rate (CRR)
Duration of Response (DOR) by IRC and Investigator Assessment
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sonrotoclax Plus ZanubrutinibExperimental Treatment2 Interventions
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)
Group II: Venetoclax Plus ObinutuzumabActive Control2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940

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Who is running the clinical trial?

BeiGeneLead Sponsor
177 Previous Clinical Trials
28,420 Total Patients Enrolled
~427 spots leftby Feb 2032
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