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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
Must not have
Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment
Clinically significant cardiovascular disease including specific conditions such as myocardial infarction within 6 months before the Screening, unstable angina within 3 months before the Screening, New York Heart Association class III or IV congestive heart failure, history of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes, and QT interval corrected by Fridericia's formula > 480 milliseconds
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My condition worsened while on ibrutinib or acalabrutinib treatment.
Select...
I have serious heart issues, including recent heart attacks or unstable angina.
Select...
I haven't had cancer treatment except immunotherapy in the last 7 days or immunotherapy in the last 4 weeks.
Select...
I have had bleeding in my brain.
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
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%
Thrombocytopenia
10%
Nausea
10%
Pyrexia
10%
Contusion
10%
Cough
10%
Headache
8%
Pneumonia
8%
Vomiting
8%
Urinary tract infection
7%
Pain in extremity
7%
Epistaxis
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%
Petechiae
5%
Abdominal pain
5%
Fall
5%
Hypokalaemia
5%
Insomnia
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%
Basal cell carcinoma
3%
Anxiety
3%
Nasopharyngitis
3%
Gout
3%
Oropharyngeal pain
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%
Pruritus
2%
Herpes zoster
2%
Cataract
2%
Blood creatinine increased
2%
Rash maculo-papular
2%
Hypogammaglobulinaemia
1%
Pleural effusion
1%
Mastoiditis
1%
Transient ischaemic attack
1%
Abdominal pain upper
1%
Death
1%
Adenocarcinoma gastric
1%
Lung adenocarcinoma
1%
Cerebral infarction
1%
Syncope
1%
Cardiac arrest
1%
Respiratory failure
1%
Influenza
1%
Hypoglobulinaemia
1%
Lymphadenopathy
1%
Angina pectoris
1%
Ventricular fibrillation
1%
Inguinal hernia
1%
Appendicitis
1%
Infection
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~2160
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
200 Previous Clinical Trials
31,400 Total Patients Enrolled
9 Trials studying Waldenstrom Macroglobulinemia
1,211 Patients Enrolled for Waldenstrom Macroglobulinemia
Dih-Yih Chen, MDStudy DirectorBeiGene
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need more than 10 mg of prednisone or similar medication daily.My condition requires treatment before starting ibrutinib or acalabrutinib.My condition worsened while on ibrutinib or acalabrutinib treatment.I have serious heart issues, including recent heart attacks or unstable angina.My blood tests show enough neutrophils and platelets for treatment.I haven't had cancer treatment except immunotherapy in the last 7 days or immunotherapy in the last 4 weeks.I have had bleeding in my brain.I can take care of myself and am up and about more than half of my waking hours.I had severe side effects from Ibrutinib or Acalabrutinib that required stopping the treatment.You have a history of specific types of heart block without a pacemaker.
Research Study Groups:
This trial has the following groups:- Group 1: Zanubrutinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.