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Bruton's Tyrosine Kinase (BTK) Inhibitor
Zanubrutinib + Tislelizumab for B-Cell Lymphoma
Phase 3
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient who is currently on zanubrutinib treatment
No known New York Heart Association (NYHA) Class III or IV congestive heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will assess the long-term safety of zanubrutinib in people with B-cell malignancies who have previously taken the drug.
Who is the study for?
This trial is for people with B-cell malignancies who were in a previous BeiGene study. They should have stable vital signs, normal organ function, and agree to birth control if needed. It's not for those with severe heart failure, uncontrolled infections, or women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial tests long-term safety of Zanubrutinib alone or with Tislelizumab in patients previously enrolled in related studies. The focus is on those who may continue benefiting from Zanubrutinib after showing no progression of disease.See study design
What are the potential side effects?
Possible side effects include digestive issues, blood disorders (like changes in platelet count), liver enzyme alterations, potential heart rhythm problems (QT interval changes), and risks associated with lowered immune defense.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently being treated with zanubrutinib.
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I do not have severe heart failure.
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I have never taken Zanubrutinib.
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I am using or willing to use effective birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events (AEs)
Secondary outcome measures
Duration of Response (DOR) per investigator assessment
Overall Survival (OS)
Progression-Free Survival (PFS) per investigator assessment
Side effects data
From 2024 Phase 3 trial • 652 Patients • NCT0373401624%
Diarrhoea
20%
Hypertension
18%
Neutropenia
16%
COVID-19
16%
Arthralgia
15%
Anaemia
14%
Upper respiratory tract infection
13%
Muscle spasms
13%
Fatigue
12%
Rash
11%
Atrial fibrillation
10%
Pyrexia
10%
Thrombocytopenia
10%
Nausea
10%
Contusion
10%
Cough
10%
Headache
8%
Pneumonia
8%
Vomiting
8%
Urinary tract infection
7%
Epistaxis
7%
Pain in extremity
7%
Peripheral swelling
7%
Constipation
7%
Oedema peripheral
7%
Back pain
7%
Dizziness
6%
Dyspepsia
6%
Neutrophil count decreased
6%
Platelet count decreased
6%
Hyperuricaemia
6%
Decreased appetite
6%
Bronchitis
5%
Abdominal pain
5%
Fall
5%
Hypokalaemia
5%
Insomnia
5%
Petechiae
4%
Palpitations
4%
Blood pressure increased
4%
Dyspnoea
4%
Gastrooesophageal reflux disease
4%
COVID-19 pneumonia
4%
Cellulitis
4%
Haematuria
4%
Sinusitis
4%
Alanine aminotransferase increased
4%
Weight decreased
4%
Haematoma
4%
Oral herpes
4%
Myalgia
4%
Squamous cell carcinoma of skin
3%
Gout
3%
Nasopharyngitis
3%
Basal cell carcinoma
3%
Oropharyngeal pain
3%
Anxiety
3%
Paronychia
3%
Skin infection
3%
Paraesthesia
3%
Conjunctivitis
3%
Mouth ulceration
3%
Asthenia
3%
Pharyngitis
3%
Aspartate aminotransferase increased
3%
Productive cough
2%
Vertigo
2%
Herpes zoster
2%
Cataract
2%
Blood creatinine increased
2%
Pruritus
2%
Rash maculo-papular
2%
Hypogammaglobulinaemia
1%
Cerebral infarction
1%
Cardiac arrest
1%
Transient ischaemic attack
1%
Adenocarcinoma gastric
1%
Respiratory failure
1%
Syncope
1%
Lung adenocarcinoma
1%
Death
1%
Pleural effusion
1%
Abdominal pain upper
1%
Influenza
1%
Hypoglobulinaemia
1%
Lymphadenopathy
1%
Angina pectoris
1%
Ventricular fibrillation
1%
Inguinal hernia
1%
Appendicitis
1%
Infection
1%
Mastoiditis
1%
Pneumocystis jirovecii pneumonia
1%
Septic shock
1%
Haemolytic anaemia
1%
Subdural haematoma
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Myocardial infarction
1%
Skin laceration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibrutinib
Zanubrutinib
Trial Design
2Treatment groups
Experimental Treatment
Group I: Zanubrutinib in combination with TislelizumabExperimental Treatment2 Interventions
Participants to receive the combination as in the parent study (Australia Only)
Group II: Zanubrutinib (BGB-3111)Experimental Treatment1 Intervention
All participants to receive open-label zanubrutinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
2018
Completed Phase 3
~4260
Zanubrutinib
2017
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,314 Total Patients Enrolled
Rainer K. Brachmann, MDStudy DirectorBeiGene
Study DirectorStudy DirectorBeiGene
1,207 Previous Clinical Trials
489,180 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently being treated with zanubrutinib.I do not have an ongoing serious infection or one that needed IV antibiotics recently.I am not currently on any chemotherapy, targeted therapy, radiation, or antibody-based treatments.I plan to start or continue taking zanubrutinib.I do not have any severe illnesses that could affect my safety or the study's results.My condition worsened while on a BTK inhibitor treatment, not including zanubrutinib.I do not have severe heart failure.I have never taken Zanubrutinib.I am using or willing to use effective birth control.
Research Study Groups:
This trial has the following groups:- Group 1: Zanubrutinib in combination with Tislelizumab
- Group 2: Zanubrutinib (BGB-3111)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the most popular conditions that Zanubrutinib has been proven to help?
"Zanubrutinib is a common treatment for waldenstrom macroglobulinemia, as well as being able to help patients manage relapsed marginal zone lymphoma, lymphoma, and one prior therapy."
Answered by AI
Do we have any other examples to compare this clinical trial against?
"Zanubrutinib has been under research since 2016. The first clinical trial, sponsored by MEI Pharma, Inc., was conducted in that year and 177 people were included. After the success of this Phase 1 study, Zanubrutinib received drug approval. As of now, there are 142 active trials for Zanubrutinib spanning 49 countries and 614 cities."
Answered by AI
Is this the first clinical trial for Zanubrutinib?
"Zanubrutinib is currently being trialed in 142 separate studies, 26 of which are Phase 3 clinical trials. Although the majority of these trials are happening in Nanning, Guangxi, there are 3336 total locations running these tests."
Answered by AI
What are some of the potential side effects that patients might experience when taking Zanubrutinib?
"Zanubrutinib's safety was scored a 3 by our Power team. A Phase 3 trial indicates that, while there is some efficacy data supporting the use of Zanubrutinib, multiple rounds of data support its safety"
Answered by AI
Are new volunteers currently being sought for this trial?
"This clinical trial is no longer recruiting patients. The listing was created on 1/21/2020 and last updated on 7/27/2022. If you are looking for other trials, there are 2451 studies actively seeking patients with b-cell malignancies and 142 trials for Zanubrutinib that are currently enrolling participants."
Answered by AI
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