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Bruton's Tyrosine Kinase (BTK) Inhibitor

Zanubrutinib vs Ibrutinib for Chronic Lymphocytic Leukemia (ALPINE 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
Confirmed diagnosis of CLL or SLL that meets the 2008 IWCLL criteria
ECOG performance status of 0, 1, or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 51 months
Awards & highlights

ALPINE Trial Summary

This trial will compare the effectiveness of two different drugs for people with a certain kind of blood cancer.

Who is the study for?
This trial is for people with a type of blood cancer called chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have tried at least one treatment before but it didn't work. They should be able to do most activities on their own, expected to live at least another 6 months, and not have any serious infections or other cancers in the last 3 years.Check my eligibility
What is being tested?
The study compares two drugs: Zanubrutinib and Ibrutinib. Both are designed to treat CLL/SLL that has come back or hasn't responded to previous treatments. The main goal is to see which drug does better at controlling the disease.See study design
What are the potential side effects?
Possible side effects include diarrhea, muscle pain, fatigue, rash, fever, bruising easily due to low platelets in the blood, shortness of breath from lung issues and heart problems like irregular heartbeat.

ALPINE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with CLL or SLL according to specific criteria.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My bone marrow is working well.
Select...
My CLL/SLL requires treatment according to specific guidelines.
Select...
My CLL/SLL has not responded to at least one treatment.

ALPINE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~51 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 51 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
ORR as Determined by Independent Review Committee (IRC)
Overall Response Rate (ORR) as Determined by Investigator Assessment
Secondary outcome measures
Duration of Response Determined by Independent Central Review
Duration of Response Determined by Investigator Assessment
Incidence of Adverse Events as Assessed by CTCAE v4.03 [Safety and Tolerability]
+8 more
Other outcome measures
Correlation Between Prognostic and Predictive Biomarkers and Clinical Outcomes

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%
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%
Transient ischaemic attack
1%
Cerebral infarction
1%
Adenocarcinoma gastric
1%
Cardiac arrest
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

ALPINE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ZanubrutinibExperimental Treatment1 Intervention
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy
Group II: IbrutinibActive Control1 Intervention
Participants received Ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
175 Previous Clinical Trials
28,162 Total Patients Enrolled
Tommi Salmi, MDStudy DirectorBeiGene
Study DirectorStudy DirectorBeiGene
1,207 Previous Clinical Trials
489,028 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other drugs in Zanubrutinib's class?

"Zanubrutinib was first trialed in 2011 at the National Institutes of Health Clinical Center. As of now, there have been 116 completed studies with 193 trials currently recruiting patients. Many of these locations are situated in Lake Success, New york."

Answered by AI

How many people are taking part in this clinical trial at most?

"As of right now, this clinical trial is no longer recruiting patients. This study was first posted on November 1st, 2018 and was last edited on December 3rd, 2021. However, there are nearly 3000 other trials for leukemia and lymphoma that are still looking for patients as well as 193 Zanubrutinib trials."

Answered by AI

When did the FDA last rule on Zanubrutinib's therapeutic use?

"Zanubrutinib has been given a safety score of 3 by our team at Power. This is due to the fact that Zanubrutinib is in Phase 3 clinical trials, meaning there is not only some data supporting its efficacy, but multiple rounds of data affirming its safety."

Answered by AI

Are people with the required qualifications currently able to enroll in this trial?

"According to the website clinicaltrials.gov, this study is not currently looking for participants. The trial was first posted on 11/1/2018 and updated last on 12/3/2021. Although not recruiting right now, there are 3143 other studies that are open to patients."

Answered by AI

What are the common applications for Zanubrutinib?

"Zanubrutinib is a medication that helps patients with mantle cell lymphoma (MCL), waldenstrom macroglobulinemia, relapsed marginal zone lymphoma, and other similar conditions."

Answered by AI

At how many facilities is this clinical trial taking place?

"Presently, this clinical trial has 41 patients. For example, Clinical Research Alliance Inc in Lake Success, SCRI Tennessee Oncology Chattanooga in Chattanooga, and Texas Oncology (Walnut) - USOR in Dallas have enrollees for the study. There are also 41 other recruiting locations."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Illinois Cancer Specialists (Niles) - USOR
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

To try a better drug than what I'm taking.
PatientReceived 1 prior treatment
Recent research and studies
Future OncologyJournal
ALPINE: Zanubrutinib Versus Ibrutinib in Relapsed/refractory Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma
Hillmen, Peter, Jennifer R Brown, Barbara F Eichhorst, Nicole Lamanna, Susan M O’Brien, Lugui Qiu, Tommi Salmi, et al.. 2020. “ALPINE: Zanubrutinib Versus Ibrutinib in Relapsed/refractory Chronic Lymphocytic Leukemia/small Lymphocytic Lymphoma”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2019-0844.
clinicaltrials.govStudy
A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
2018. "A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03734016.
~102 spots leftby Apr 2025
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