Chronic Lymphocytic Leukemia Clinical Trial

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

Summary

This study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory leukemia-cll/" >chronic lymphocytic leukemia or small lymphocytic lymphoma.

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Full Description

This is a global, Phase 3, randomized study of zanubrutinib versus ibrutinib in 652 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

The primary efficacy endpoint is overall response rate determined by investigator assessment. Participants were randomized in a 1:1 manner to either zanubrutinib or ibrutinib. Treatment with zanubrutinib and ibrutinib was open label.

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Eligibility Criteria

Key Inclusion Criteria

Confirmed diagnosis of CLL or SLL that meets the 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
CLL/SLL requiring treatment per 2008 IWCLL criteria
Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL
Measurable disease by Computerized Tomography (CT)/magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Life expectancy ≥ 6 months
Adequate bone marrow function
Adequate renal and hepatic function

Key Exclusion Criteria

Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
Clinically significant cardiovascular disease.
Prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast
History of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention
History of stroke or intracranial hemorrhage within 180 days before first dose of study drug
Severe or debilitating pulmonary disease
Active fungal, bacterial, and/or viral infection requiring systemic therapy
Known central nervous system involvement by leukemia or lymphoma
Known infection with HIV or active viral hepatitis B or C infection
Moderate or severe hepatic impairment, ie, Child-Pugh class B or C
Major surgery within 4 weeks of the first dose of study drug
Prior treatment with a (Burton's Kinase) BTK inhibitor
Toxicity from prior anticancer therapy that has not recovered to ≤ Grade 1
Pregnant or lactating women
Vaccination with a live vaccine within 35 days prior to the first dose of study drug
Hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug
Concurrent participation in another therapeutic clinical trial

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

652

Study ID:

NCT03734016

Recruitment Status:

Completed

Sponsor:

BeiGene

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There are 9 Locations for this study

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Interhem Opieka Szpitalna
Bialystok , 15748, Poland
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozow , 36-20, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Chorzow , 41-50, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk , 80-95, Poland
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
Gdask , 80-21, Poland
Malopolskie Centrum Medyczne Sc
Krakow , 30-51, Poland
Wojewodzki Szpital Specjalistyczny W Legnicy
Legnica , 59-22, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz , 93-51, Poland
Examen Sp Z Oo
Poznan , 60-56, Poland

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 3

Estimated Enrollment:

652

Study ID:

NCT03734016

Recruitment Status:

Completed

Sponsor:


BeiGene

How clear is this clinincal trial information?

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