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Bruton Tyrosine Kinase Inhibitor

Zanubrutinib for Lymphoma

Phase 2
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib
Absolute neutrophil count (ANC) ≥ 1000/mm^3 with or without growth factor support and platelet count ≥ 50,000/mm^3 (may be post-transfusion), on or prior to C1D1 of zanubrutinib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will evaluate the safety of zanubrutinib in cancer patients who have become intolerant to prior ibrutinib and/or acalabrutinib treatment.

Who is the study for?
This trial is for people with certain B-cell lymphomas or leukemia who had bad reactions to previous treatments with ibrutinib or acalabrutinib. They should be relatively active (ECOG status of 0-2), have a minimum number of neutrophils and platelets, and not have severe heart problems, recent heart attacks, CNS hemorrhage, or need high doses of steroids.Check my eligibility
What is being tested?
The study tests Zanubrutinib's safety in patients intolerant to prior BTKi treatments. It looks at whether the side effects are less severe or occur less often than before. Patients previously treated with other cancer therapies must wait specific periods before joining.See study design
What are the potential side effects?
While the trial primarily assesses safety, potential side effects may include those common to BTK inhibitors such as bruising, diarrhea, fatigue, fever, muscle pain and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition requires treatment before starting ibrutinib or acalabrutinib.
Select...
My blood tests show enough neutrophils and platelets for treatment.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest.
Secondary outcome measures
Disease control rate as determined by investigator
Overall response as determined by investigator
Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D)
+2 more

Side effects data

From 2024 Phase 3 trial • 652 Patients • NCT03734016
24%
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%
Blood pressure increased
4%
Palpitations
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%
Nasopharyngitis
3%
Oropharyngeal pain
3%
Gout
3%
Basal cell carcinoma
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%
Syncope
1%
Lung adenocarcinoma
1%
Respiratory failure
1%
Adenocarcinoma gastric
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

1Treatment groups
Experimental Treatment
Group I: ZanubrutinibExperimental Treatment1 Intervention
Cohort 1: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with ibrutinib Cohort 2: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with acalabrutinib alone/with ibrutinib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
177 Previous Clinical Trials
28,955 Total Patients Enrolled
Dih-Yih Chen, MDStudy DirectorBeiGene

Media Library

Zanubrutinib (Bruton Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04116437 — Phase 2
Marginal Zone Lymphoma Research Study Groups: Zanubrutinib
Marginal Zone Lymphoma Clinical Trial 2023: Zanubrutinib Highlights & Side Effects. Trial Name: NCT04116437 — Phase 2
Zanubrutinib (Bruton Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04116437 — Phase 2
~19 spots leftby Oct 2025
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