← Back to Search

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

Select...

My condition requires treatment before starting ibrutinib or acalabrutinib.

Select...

My blood tests show enough neutrophils and platelets for treatment.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Pneumonia

Vomiting

Urinary tract infection

Pain in extremity

Epistaxis

Peripheral swelling

Constipation

Oedema peripheral

Back pain

Dizziness

Dyspepsia

Neutrophil count decreased

Platelet count decreased

Hyperuricaemia

Decreased appetite

Bronchitis

Abdominal pain

Fall

Hypokalaemia

Insomnia

Petechiae

Blood pressure increased

Palpitations

Dyspnoea

Gastrooesophageal reflux disease

COVID-19 pneumonia

Cellulitis

Haematuria

Sinusitis

Alanine aminotransferase increased

Weight decreased

Haematoma

Oral herpes

Myalgia

Squamous cell carcinoma of skin

Nasopharyngitis

Oropharyngeal pain

Gout

Basal cell carcinoma

Anxiety

Paronychia

Skin infection

Paraesthesia

Conjunctivitis

Mouth ulceration

Asthenia

Pharyngitis

Aspartate aminotransferase increased

Productive cough

Vertigo

Herpes zoster

Cataract

Blood creatinine increased

Pruritus

Rash maculo-papular

Hypogammaglobulinaemia

Cardiac arrest

Cerebral infarction

Lung adenocarcinoma

Respiratory failure

Transient ischaemic attack

Syncope

Adenocarcinoma gastric

Death

Pleural effusion

Abdominal pain upper

Influenza

Hypoglobulinaemia

Lymphadenopathy

Angina pectoris

Ventricular fibrillation

Inguinal hernia

Appendicitis

Infection

Mastoiditis

Pneumocystis jirovecii pneumonia

Septic shock

Haemolytic anaemia

Subdural haematoma

Acute kidney injury

Acute respiratory failure

Myocardial infarction

Skin laceration

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,735 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently partaking in this clinical experiment?

"This clinical trial necessitates 90 patients, who all comply with the established inclusion criteria. Patients have their pick of multiple locations to partake in this experiment, including Abington Hematology Oncology Associates in Drexel Hill, Pennsylvania and SSM Health Cancer Care- Dean M in Madison, Wisconsin."

Answered by AI

What other research findings have been ascertained regarding Zanubrutinib?

"Presently, 37 clinical trials are testing the effectiveness of Zanubrutinib with 8 in their final phase. Guangzhou, Guangdong is at the epicenter of this research; however, there are 1104 sites carrying out these studies worldwide."

Answered by AI

What medical conditions commonly respond to Zanubrutinib treatment?

"Zanubrutinib is typically utilised to treat waldenstrom macroglobulinemia, yet it has also proved effective for relapsed marginal zone lymphoma, lymphoma and one prior therapy."

Answered by AI

Is this a pioneering clinical trial in its field?

"Zanubrutinib's journey began in 2016 with an exploratory Phase 1 trial conducted by MEI Pharma, Inc. and comprising 177 patients. Subsequently it was approved for further clinical trials which currently involve 37 studies being held across 324 cities spanning 32 countries worldwide."

Answered by AI

Is this research effort currently seeking new participants?

"In accordance with clinicaltrials.gov, this research endeavor is actively searching for volunteers to participate in the study which was initially advertised on October 15th 2019 and revised as recently as September 6th 2022."

Answered by AI

Are there any known risks associated with using Zanubrutinib for patients?

"Based on the available evidence, Zanubrutinib was assessed a score of 2; while there is some data to suggest its safety, no studies have yet been conducted to support efficacy."

Answered by AI

Are there any geographic limitations on the current implementation of this experiment?

"This clinical trial is taking place at 38 different medical sites, including Drexel Hill, Madison and Green Bay. Therefore it is recommended that interested parties select the closest centre to them in order to reduce travel demands associated with participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment

2019. "Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04116437.

All > Waldenstrom Macroglobulinemia