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Monoclonal Antibodies

Sonrotoclax + Zanubrutinib vs Venetoclax + Obinutuzumab 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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 9 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

CRR by Investigator Assessment

Complete Response Rate (CRR)

Duration of Response (DOR) by IRC and Investigator Assessment

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2160

0 / 4Eligibility criteria met