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A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL

NCT03336333 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 590

Last updated 2026-03-09

Study results available
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Summary

To compare efficacy between zanubrutinib versus bendamustine and rituximab in patients with previously untreated CLL/SLL, as measured by progression free survival assess by Independent Central Review.

Conditions

Interventions

DRUG

Zanubrutinib

Administered as two 80-milligram (mg) capsules by mouth twice a day (160 mg twice a day)

DRUG

Bendamustine

Administered intravenously (IV) at a dose of 90 mg/m\^2/day on the first 2 days of each cycle for 6 cycles.

DRUG

Rituximab

Administered intravenously (IV) at a dose of 375 mg/m\^2 on day 0 of cycle 1, and at a dose of 500 mg/m\^2 on day 1 of cycles 2 to 6

DRUG

Venetoclax

400 mg tablets administered orally once daily.

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2021-05-07
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • China
  • Czechia
  • France
  • Italy
  • New Zealand
  • Poland
  • Russia
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336333 on ClinicalTrials.gov