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Chemotherapy
Zanubrutinib vs Bendamustine + Rituximab for Chronic Lymphocytic Leukemia (SEQUOIA Trial)
Phase 3
Waitlist Available
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate bone marrow function
Unsuitable for chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab (FCR)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
SEQUOIA Trial Summary
This trial is comparing the effectiveness of zanubrutinib to a combination of bendamustine and rituximab in patients who have not been treated for CLL/SLL before, as measured by how long they live without the disease progressing.
Who is the study for?
This trial is for adults with previously untreated CLL or SLL who can't have standard chemoimmunotherapy. They should be relatively healthy (ECOG 0-2), expect to live at least 6 more months, and have good organ function. People with prior CLL/SLL treatment, ongoing infections, certain heart diseases, recent major surgery, pregnancy, drug addiction or other serious health issues cannot join.Check my eligibility
What is being tested?
The study tests Zanubrutinib's effectiveness against Bendamustine plus Rituximab in treating CLL/SLL without prior treatments. It measures how long patients stay disease-free as judged by an independent review. Participants are randomly assigned to receive either the new therapy or the existing one.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medication components, liver and kidney problems due to toxicity of drugs like Zanubrutinib and Venetoclax; infusion-related reactions from Rituximab; blood disorders from Bendamustine; and general risks such as fatigue and infection.
SEQUOIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My bone marrow is working well.
Select...
I cannot receive the standard chemoimmunotherapy for my condition.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have CD20-positive CLL or SLL and need treatment.
SEQUOIA Trial 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
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR)
Secondary outcome measures
Apparent Rate of Clearance of Zanubrutinib From Plasma (CL/F)CL/F
Cohort 1 Zanubrutinib Only Arms: Area-Under-Curve From Time 0 to 12 Hours Postdose (AUC0-12)
Cohort 1: Duration of Response (DOR) Between Treatment Groups as Determined by the ICR
+17 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%
Gout
3%
Nasopharyngitis
3%
Basal cell carcinoma
3%
Oropharyngeal pain
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%
Cerebral infarction
1%
Cardiac arrest
1%
Transient ischaemic attack
1%
Adenocarcinoma gastric
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
SEQUOIA Trial Design
6Treatment groups
Experimental Treatment
Group I: Cohort 3: Venetoclax + ZanubrutinibExperimental Treatment2 Interventions
Approximately 110 participants, 50 without del17p and 60 with del[17p] or TP53 mutation will receive zanubrutinib plus venetoclax; Participants will also receive zanubrutinib starting on Cycle 1 Day 1 then daily for a minimum of 27 cycles, or until unacceptable toxicity or disease progression, whichever occurs first. Participants will receive venetoclax starting Cycle 4 Day 1 according to a 5-week dose-up schedule then daily until unacceptable toxicity, disease progression, or for a maximum of 24 cycles. Each cycle is 28 days. (Arm D)
Group II: Cohort 2: ZanubrutinibExperimental Treatment1 Intervention
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm C)
Group III: Cohort 1a (China only): ZanubrutinibExperimental Treatment1 Intervention
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A, China only)
Group IV: Cohort 1a (China only): Bendamustine + RituximabExperimental Treatment2 Interventions
Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B, China only)
Group V: Cohort 1: ZanubrutinibExperimental Treatment1 Intervention
Participants will receive zanubrutinib until unacceptable toxicity or disease progression (Arm A)
Group VI: Cohort 1: Bendamustine + RituximabExperimental Treatment2 Interventions
Participants will receive bendamustine plus rituximab for up to six 28-day cycles (Arm B)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1990
Zanubrutinib
2017
Completed Phase 3
~1940
Rituximab
1999
Completed Phase 4
~1880
Bendamustine
2015
Completed Phase 3
~2950
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
175 Previous Clinical Trials
28,224 Total Patients Enrolled
32 Trials studying Lymphoma
4,548 Patients Enrolled for Lymphoma
Study DirectorStudy DirectorBeiGene
1,207 Previous Clinical Trials
489,090 Total Patients Enrolled
42 Trials studying Lymphoma
10,648 Patients Enrolled for Lymphoma
Jason Paik, MD, PhDStudy DirectorBeiGene
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently struggling with alcohol or drug addiction.I need continuous treatment with a strong CYP3A inhibitor or inducer.I have or might have had a change in my leukemia to a more aggressive form.I have a serious heart condition.I haven't had cancer in the last 3 years, except for certain non-aggressive types.My leukemia or lymphoma has spread to my brain or spinal cord.I do not have HIV or active hepatitis B or C.My bone marrow is working well.My kidney and liver are functioning well.I have not had a stroke or brain bleed in the last 6 months.I have not had major surgery in the last 4 weeks.I cannot swallow pills or have a digestive system condition.I have a history of severe bleeding problems.I have received treatment for CLL/SLL before.I am allergic to zanubrutinib, bendamustine, rituximab, or venetoclax.I am currently being treated for an infection.I need to keep taking corticosteroids.I cannot receive the standard chemoimmunotherapy for my condition.I can take care of myself and am up and about more than half of my waking hours.I have a severe lung condition that greatly affects my daily life.I have not received a live vaccine in the last 35 days.I have CD20-positive CLL or SLL and need treatment.I have a health condition that could make the study drug dangerous for me.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1a (China only): Bendamustine + Rituximab
- Group 2: Cohort 1: Zanubrutinib
- Group 3: Cohort 2: Zanubrutinib
- Group 4: Cohort 3: Venetoclax + Zanubrutinib
- Group 5: Cohort 1: Bendamustine + Rituximab
- Group 6: Cohort 1a (China only): Zanubrutinib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 there any patients who can still join this trial?
"No, this study is not recruiting patients according to the latest information from clinicaltrials.gov. This particular trial was posted on 11/2/2017 and updated for the last time on 6/24/2022; however, there are many other trials (3619 in total) that are actively looking for candidates."
Answered by AI
Could you please discuss the potential risks associated with Zanubrutinib?
"Zanubrutinib is a Phase 3 trial drug, which means that while there is some efficacy data to support its use, there are also multiple rounds of safety data. Power team rates it as having a level 3 safety risk."
Answered by AI
Are there other scientific papers which mention Zanubrutinib?
"Zanubrutinib is being trialed in 669 ongoing studies, with 123 of those trials currently in Phase 3. While a large portion of these tests are taking place in Edmonton, Alberta, there are 21997 total locations running clinical trials for Zanubrutinib."
Answered by AI
How many individuals fit the bill for this clinical research?
"This study is no longer recruiting participants. Originally posted on November 2nd, 2017 and last edited on June 24th, 2029, this clinical trial has completed its recruitment drive. There are presently 2950 studies actively searching for participants with lymphoma and 669 trials for Zanubrutinib actively looking for patients."
Answered by AI
What are the most frequent indications for Zanubrutinib?
"Zanubrutinib is most often used to treat b-cell lymphomas, but it can also be prescribed for other conditions like polyangium and one prior therapy."
Answered by AI
Is this clinical trial being conducted in many hospitals throughout North America?
"Presently, there are 8 hospitals enrolling patients in this trial. Some notable locations include Fred Hutchinson Cancer Research Center in Seattle, Northwestern University in Chicago, and Oregon Health & Science University in Portland."
Answered by AI
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