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NCT03734016 · ClinicalTrials.gov registry record · Phase 3

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

A Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by BeiGene.

Completed
Registry status
Phase 3
Development phase
652
Enrollment target
20
Study locations

NCT03734016: Completed Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by BeiGene.

NCT03734016 is a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that has completed, run by BeiGene. The registered enrollment target is 652 participants, above the 178-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (266% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03734016, a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, has completed, sponsored by BeiGene.

COMPLETED
Registry status
Phase 3
Development phase
652 participants
Enrollment target
20
Study locations

Study Summary

This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

Primary Outcome

ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per investigator assessment. Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL.

Conditions Studied

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Interventions

  • DRUG Zanubrutinib
  • DRUG Ibrutinib

Study Locations (20)

Florida

  • Scri Florida Cancer Specialists South - Fort Myers
  • Scri Florida Cancer Specialists North - St. Petersburg

New Jersey

  • Atlantic Health System - Morristown
  • Morristown Medical Center - Morristown

New York

  • Columbia University Medical Center - New York
  • Clinical Research Alliance, Inc - Westbury

Oregon

  • Oregon Health and Science University - Portland
  • Willamette Valley Cancer Center - Springfield

Arkansas

  • Carti Cancer Center - Little Rock

California

  • David Geffen School of Medicine At UCLA - Los Angeles

Colorado

  • Rocky Mountain Cancer Centers Boulder - Boulder

Georgia

  • Augusta University - Augusta

Trial Details

FieldValue
Enrollment Target 652 participants
Start Date 2018-11-01
Est. Completion 2024-02-28
Phase Phase 3
BeiGene

65 total trials

What the finished NCT03734016 record still lists

NCT03734016 is an interventional study that assigns participants to a tested intervention. The registered 652 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (266% higher).

The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Zanubrutinib is the first listed.

NCT03734016 names 20 study sites across 16 states, led by Florida, New Jersey, New York.

Frequently Asked Questions

What is clinical trial NCT03734016 about?

NCT03734016 is a clinical study titled "A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia". This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

What is the current status of trial NCT03734016?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 652 participants. The study started on 2018-11-01. Estimated completion is 2024-02-28.

What conditions does trial NCT03734016 study?

This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.

What interventions are being tested in trial NCT03734016?

The interventions under investigation include: Zanubrutinib (DRUG), Ibrutinib (DRUG).

Who is sponsoring clinical trial NCT03734016?

This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03734016 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Chronic Lymphocytic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03734016's enrollment target sits among peer trials

652 11th of 187 higher than 177 of 187 other Chronic Lymphocytic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03734016, the US trial registry maintained by the National Library of Medicine. NCT03734016 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.