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Clinical Trials in China / NCT04170283
Active, not recruiting Phase 3

A Study to Evaluate Long-term Safety of Zanubrutinib Regimens in Participants With B-Cell Malignancies Who Participated in BeiGene Parent Studies of Zanubrutinib

NCT04170283 · tracked via the Priya Life Science China tracker
Sponsor
BeOne Medicines
Phase
Phase 3
Started
2020-01-16
Last updated
2026-08-28

Condition(s) studied

B-cell Malignancies

Investigational drug(s) / intervention(s)

ZanubrutinibTislelizumab

Zanubrutinib: Participants will receive a total dose of 320 mg daily, given either as 160 mg BID or 320 mg QD, or the last dose level received in the sponsor parent study.

Tislelizumab: Patients in Australia who participated in a parent study that involved combination therapy of zanubrutinib and tislelizumab will receive tislelizumab at a dose of 200mg every 3 weeks.

Study summary

The purpose of this study is to learn about the long-term safety and effectiveness of zanubrutinib in people with B-cell cancers who took part in an earlier zanubrutinib study. Participants continued receiving zanubrutinib if they were still benefiting from it, or they might have taken part in long-term follow-up after treatment. Information collected in this study will help health authorities better understand the long-term effects of zanubrutinib.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
1. Currently participating or participated recently in a BeOne (previously BeiGene) parent study 2. Intent to continue or start zanubrutinib treatment after any of the following: 1. At time of final analysis or study closure of the eligible BeOne (previously BeiGene) parent study 2. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest 3. At an alternative timepoint for an alternative reason 3. Patient who is currently on zanubrutinib treatment: Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment 4. Zanubrutinib-naive patient: Must meet the following criteria ≤ 15 days before first dose of study drug: 1. Platelets ≥ 50,000/mm3 2. Absolute neutrophil count ≥ 750/mm3 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal 4. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome) 5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec 6. No known New York Heart Association (NYHA) Class III or IV congestive heart failure 7. Creatinine clearance ≥ 30 mL/min 5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control. Key Exclusion Criteria: 1. Permanently discontinued from zanubrutinib treatment in the BeOne (previously BeiGene) parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent 2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy 3. Life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk 4. Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol 5. Pregnant or lactating woman 6. Inability to comply with study procedures 7. Concurrent participation in another therapeutic clinical study 8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib) NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcome measure(s)

Trial sites (153)

FacilityCityRegionStatus
Banner Md Anderson Cancer Center Gilbert Arizona
Carti Cancer Center Little Rock Arkansas
Rocky Mountain Cancer Centers Centennial Centennial Colorado
Colorado Blood Cancer Institute Denver Colorado
Florida Cancer Specialists Fort Myers Fort Myers Florida
Scri Florida Cancer Specialists North St. Petersburg Florida
Dana Farber Cancer Institute Boston Massachusetts
University of Michigan Health System Ann Arbor Michigan
Mayo Clinic Rochester Rochester Minnesota
Forrest General Hospital Cancer Center Hattiesburg Mississippi
University of Nebraska Medical Center Omaha Nebraska
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
Summit Medical Group Florham Park New Jersey
Atlantic Health System Morristown New Jersey
Optum Medical Care, Pc. Westbury New York
Duke University Hospital Durham North Carolina
Oncology Associates of Oregon Willamette Valley Cancer Center Eugene Oregon
Oregon Health and Science University Portland Oregon
Scri Tennessee Oncology Chattanooga Chattanooga Tennessee
Tennessee Oncology Nashville Tennessee
Texas Oncology Fort Worth Cancer Center Fort Worth Texas
The University of Texas Md Anderson Cancer Center Houston Texas
Texas Oncology San Antonio Medical Center Usor San Antonio Texas
Oncology and Hematology Associates of Southwest Virginia, Inc Roanoke Virginia
University of Washington Seattle Cancer Alliance Seattle Washington
Medical Oncology Associates Spokane Washington
Paratus Clinical Research Woden Canberra Australian Capital Territory
Concord Repatriation General Hospital Concord New South Wales
Border Medical Oncology East Albury New South Wales
St George Hospital Kogarah New South Wales
Royal North Shore Hospital St Leonards New South Wales
Calvary Mater Newcastle Waratah New South Wales
Westmead Hospital Westmead New South Wales
Icon Cancer Centre Wesley Auchenflower Queensland
Princess Alexandra Hospital Brisbane Queensland
Brisbane Clinic For Lymphoma Greenslopes Queensland
John Flynn Private Hospital Tugun Queensland
Royal Adelaide Hospital Adelaide South Australia
Flinders Medical Centre Bedford PK South Australia
Icon Cancer Centre Kurralta Park Kurralta Park South Australia

+ 113 more sites — see the full list on the official registry below.

On this site

📄 Brukinsa (zanubrutinib) drug profile →

More BeOne Medicines trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04170283 on ClinicalTrials.gov ↗ ← All trials in China