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Active (not recruiting) Phase 3 NCT04170283

Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

Phase 3 – large-scale trial before approval
Conditions: B-cell Malignancies

Sponsor: BeiGene

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.
Who can participate
1. Currently participating or participated recently in a 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 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 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
Locations 17
Australia (1)
Paratus Clinical Research Woden
Canberra , Australian Capital Territory
China (1)
Peking University Third Hospital
Beijing , Beijing Municipality
Czech Republic (1)
Fakultni Nemocnice Brno
Brno
France (1)
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux
Germany (1)
Srh Kliniken Landkreis Sigmaringen
Sigmaringen
Greece (1)
General Hospital of Athens Alexandra
Athens
Italy (1)
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna
Japan (1)
Toyohashi Municipal Hospital
Toyohashi , Aichi-ken
Netherlands (1)
Amsterdam Umc Amc
Amsterdam
New Zealand (1)
Auckland City Hospital
Auckland
Poland (1)
Interhem Opieka Szpitalna
Bialystok
South Korea (1)
Inje University Busan Paik Hospital
Busan , Busan Gwang'yeogsi
Spain (1)
Hospital de La Santa Creu I Sant Pau
Barcelona
Sweden (1)
Skanes Universitetssjukhus I Lund
Lund
Turkey (1)
Namik Kemal University
Tekirdağ
United Kingdom (1)
Nhs Grampian Ppds
Aberdeen
United States (1)
Banner Md Anderson Cancer Center
Gilbert , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.01.2020
Completion date
01.12.2028
Registry ID
NCT04170283
Source
anzctr
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