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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 below

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My condition requires treatment before starting ibrutinib or acalabrutinib.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition worsened while on ibrutinib or acalabrutinib treatment.

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I have serious heart issues, including recent heart attacks or unstable angina.

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I haven't had cancer treatment except immunotherapy in the last 7 days or immunotherapy in the last 4 weeks.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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%

Thrombocytopenia

10%

Nausea

10%

Pyrexia

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

Petechiae

Abdominal pain

Fall

Hypokalaemia

Insomnia

Palpitations

Blood pressure increased

Dyspnoea

Gastrooesophageal reflux disease

COVID-19 pneumonia

Cellulitis

Haematuria

Sinusitis

Alanine aminotransferase increased

Weight decreased

Haematoma

Oral herpes

Myalgia

Squamous cell carcinoma of skin

Basal cell carcinoma

Anxiety

Nasopharyngitis

Gout

Oropharyngeal pain

Paronychia

Skin infection

Paraesthesia

Conjunctivitis

Mouth ulceration

Asthenia

Pharyngitis

Aspartate aminotransferase increased

Productive cough

Vertigo

Pruritus

Herpes zoster

Cataract

Blood creatinine increased

Rash maculo-papular

Hypogammaglobulinaemia

Pleural effusion

Mastoiditis

Transient ischaemic attack

Abdominal pain upper

Death

Adenocarcinoma gastric

Lung adenocarcinoma

Cerebral infarction

Syncope

Cardiac arrest

Respiratory failure

Influenza

Hypoglobulinaemia

Lymphadenopathy

Angina pectoris

Ventricular fibrillation

Inguinal hernia

Appendicitis

Infection

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

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

0 / 7Eligibility criteria met