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B-cell Lymphoma-2 (BCL-2) Inhibitor
Zanubrutinib + Venetoclax for Chronic Lymphocytic Leukemia
Phase 2
Recruiting
Led By Inhye E Ahn, MD
Research Sponsored by Jennifer R. Brown, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have adequate organ function as defined below: Platelet count ≥ 20,000/mcL, Total bilirubin ≤ 2 × institutional upper limit of normal (ULN) (unless due to controlled hemolysis, Gilbert's disease, or is of non-hepatic origin), AST (SGOT) and ALT (SGPT) ≤ 4 × institutional ULN, Serum Creatinine ≤ 1.5 × institutional ULN, OR Calculated creatinine clearance ≥ 50 mL/min (as calculated by the Cockcroft-Gault formula)
Age ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 3 years after treatment initiation
Awards & highlights
Study Summary
This trial is testing whether combining these two drugs will work better to treat CLL/SLL than either drug alone.
Who is the study for?
Adults with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need therapy and have not used certain inhibitors. They must be in stable health, understand the study, agree to use contraception, and have no history of certain other diseases or recent treatments that could affect safety.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs, zanubrutinib and venetoclax, for their effectiveness against CLL/SLL in patients who've had previous treatment. It's designed to see how well these drugs work together after initial therapies.See study design
What are the potential side effects?
Potential side effects may include digestive issues, blood disorders like anemia or bleeding problems, infections due to a weakened immune system, liver function changes, fatigue, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I can take care of myself but might not be able to do active work.
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I can swallow and keep down pills.
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My condition worsened after my first treatment and I now need more treatment.
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I have not taken BTK or BCL-2 inhibitors like ibrutinib or acalabrutinib.
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My condition worsened while on a BTK inhibitor treatment, but not zanubrutinib.
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I have been diagnosed with CLL or SLL according to the 2018 IWCLL guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 and 3 years after treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 3 years after treatment initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of undetectable minimal residual disease (uMRD)
Secondary outcome measures
Complete Response (CR) Rate
Heart rate
Overall survival (OS)
+3 moreSide 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%
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%
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%
Oropharyngeal pain
3%
Nasopharyngitis
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%
Adenocarcinoma gastric
1%
Cerebral infarction
1%
Cardiac arrest
1%
Transient ischaemic attack
1%
Respiratory failure
1%
Syncope
1%
Lung adenocarcinoma
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
3Treatment groups
Experimental Treatment
Group I: Cohort C: BTKi exposed and with disease progressionExperimental Treatment2 Interventions
Participants who experienced disease progression on a prior BTK inhibitor. Participants with BTK C481X mutation at enrollment will be excluded.
Group II: Cohort B: BTKi or BCL2i exposed without disease progressionExperimental Treatment2 Interventions
Participants who have received prior treatment with a BTK or BCL-2 inhibitor and discontinued treatment for any reason other than disease progression
Group III: Cohort A: BTKi and BCL2i naiveExperimental Treatment2 Interventions
Participants who have never received a BTK inhibitor or a BCL-2 inhibitor
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940
Venetoclax
2019
Completed Phase 3
~1990
Find a Location
Who is running the clinical trial?
Jennifer R. Brown, MD, PhDLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,769 Total Patients Enrolled
33 Trials studying Lymphoma
5,138 Patients Enrolled for Lymphoma
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,941 Total Patients Enrolled
60 Trials studying Lymphoma
2,386 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious heart condition that is currently affecting me.I am 18 years old or older.I agree to use birth control during the study.I can take care of myself but might not be able to do active work.I finished IV antibiotics for an infection less than a week ago or have an ongoing infection.I can swallow and keep down pills.My condition worsened after my first treatment and I now need more treatment.I am not taking any strong or moderate drugs that affect enzyme CYP3A.I do not have any severe illnesses that could risk my safety or affect the trial's results.I have been treated with both BTK and BCL-2 inhibitors.My condition worsened while on a BTK inhibitor treatment, but not zanubrutinib.I have an active autoimmune condition affecting my blood.I have not received any live vaccines in the last 4 weeks.I haven't had cancer treatment in the last 2 weeks, with some exceptions.I do not have major issues with my stomach or intestines that affect how I digest food.I have not had a stroke, brain bleed, or major bleeding in the last 6 months.I have a history of HIV, hepatitis C, or hepatitis B.I have been diagnosed with CLL or SLL according to the 2018 IWCLL guidelines.I have been treated with either a BTK or BCL-2 inhibitor, but not both, and my disease did not worsen during treatment.I have not taken BTK or BCL-2 inhibitors like ibrutinib or acalabrutinib.My cancer has a BTK C481X mutation.My cancer has spread to my brain or spinal cord.I need warfarin or similar medications for blood thinning.I have had cancer before, but it's one of the exceptions.I have a bleeding disorder or hemophilia.I have had a stem cell transplant from a donor.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A: BTKi and BCL2i naive
- Group 2: Cohort C: BTKi exposed and with disease progression
- Group 3: Cohort B: BTKi or BCL2i exposed without disease progression
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any more participants being accepted for this research project?
"According to the information hosted on clinicaltrials.gov, this trial is actively in search of participants. The initial posting date for this study was February 18th 2022 and it most recently updated November 14th 2022."
Answered by AI
What potential risks might patients face while taking Zanubrutinib?
"Zanubrutinib's safety is rated 2, as the compound has been studied in a Phase 2 trial. While there are indications of its security, no efficacy trials have yet been conducted to confirm this drug's effectiveness."
Answered by AI
What conditions has Zanubrutinib been used to treat?
"Zanubrutinib is frequently employed to treat small lymphocytic lymphoma, with positive results also seen in patients with other conditions such as rituximab-refractory lymphomas."
Answered by AI
What is the enrollment capacity of this clinical trial?
"Affirmative. Clinicaltrials.gov details that the trial, initially advertised on February 18th 2022, is presently enlisting candidates. 45 individuals are sought from 4 distinct facilities for this study."
Answered by AI
Have there been any past endeavors to determine the efficacy of Zanubrutinib?
"Presently, there are 252 live clinical trials exploring the potential of Zanubrutinib with 35 in Phase 3. Most locations conducting these studies are situated around Antwerpen and New york but across 8108 sites globally."
Answered by AI
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