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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.
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I had severe side effects from Ibrutinib or Acalabrutinib that required stopping the treatment.

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 2020 Phase 2 trial • 41 Patients • NCT03145064
22%
Neutrophil count decreased
17%
Hypokalaemia
12%
Platelet count decreased
10%
Blood creatinine increased
10%
Lymphocyte count decreased
10%
Cough
10%
Rash
10%
Hypertension
10%
White blood cell count decreased
10%
Constipation
10%
Diarrhoea
10%
Urinary tract infection
7%
Pneumonia
7%
Anaemia
7%
Leukopenia
7%
Upper respiratory tract infection
7%
Arthralgia
7%
Back pain
7%
Alanine aminotransferase increased
7%
Aspartate aminotransferase increased
7%
Weight decreased
5%
Skin infection
5%
Rash maculo-papular
5%
Lymph node pain
5%
Malaise
5%
Oedema peripheral
5%
Nasopharyngitis
5%
Influenza like illness
5%
Tinnitus
5%
Death
5%
Blood alkaline phosphatase increased
5%
Blood bilirubin increased
5%
Decreased appetite
5%
Hyperglycaemia
5%
Hypertriglyceridaemia
5%
Hyperuricaemia
5%
Hypoalbuminaemia
2%
Cataract
2%
Intestinal obstruction
2%
Gait inability
2%
Metabolic acidosis
2%
Sudden hearing loss
2%
Liver injury
2%
Abdominal pain
2%
Abdominal infection
2%
Herpes zoster
2%
Otitis media chronic
100%
80%
60%
40%
20%
0%
Study treatment Arm
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 2
~1270

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
173 Previous Clinical Trials
27,916 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
~23 spots leftby Oct 2025