A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Efficacy and Safety of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

BeiGene13 sites in 1 country86 target enrollmentMarch 2, 2017

ConditionsRefractory Mantle Cell Lymphoma Relapsed Mantle Cell Lymphoma

InterventionsZanubrutinib

DrugsZanubrutinib

Overview

Phase: Phase 2
Intervention: Zanubrutinib
Conditions: Refractory Mantle Cell Lymphoma
Sponsor: BeiGene
Enrollment: 86
Locations: 13
Primary Endpoint: Overall Response Rate (ORR) As Assessed By Independent Review Committee
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study was to evaluate the efficacy of zanubrutinib in participants with centrally confirmed relapsed or refractory MCL.

Registry

clinicaltrials.gov

Start Date

March 2, 2017

End Date

September 8, 2020

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

BeiGene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnostic report had to include evidence for morphological and cyclin D1 or t (11; 14).
•Eastern Cooperative Oncology Group performance status of 0-
•Measurable disease by computed tomography/magnetic resonance imaging.
•Received prior regimens for MCL.
•Documented failure to achieve any response, (stable disease or progressive disease during treatment) or documented progressive disease after response to the most recent treatment regimen.
•Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN).
•Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome).
•Life expectancy of \> 4 months.

Exclusion Criteria

•Current or history of central nervous system lymphoma.
•Prior exposure to a BTK inhibitor before enrollment.
•Prior corticosteroids with anti-neoplastic intent within 7 days.
•Major surgery within 4 weeks of screening.
•Toxicity must have recovered from prior chemotherapy.
•History of other active malignancies within 2 years of study entry.
•Currently clinically significant active cardiovascular disease.
•QT interval corrected with Fridericia's formula \> 450 microseconds or other significant electrocardiogram abnormalities.
•Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
•Known human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction).

Arms & Interventions

Zanubrutinib

Zanubrutinib (160 milligrams) administered orally twice daily

Intervention: Zanubrutinib

Outcomes

Primary Outcomes

Overall Response Rate (ORR) As Assessed By Independent Review Committee

Time Frame: Up to 1 year and 11 months

The ORR was assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria. The ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). The BOR was defined as the best response recorded from the start of zanubrutinib until data cut or start of new antineoplastic treatment. Participants with no post-baseline response assessment (due to any reason) were considered non-responders for BOR.

Secondary Outcomes

ORR As Assessed By The Investigator(Up to 3 years and 6 months)
Number Of Participants Experiencing AEs Leading To Treatment Discontinuation(From the initiation of study drug until 30 days after the last dose (Up to 3 years and 6 months))
Time To Response(Up to 3 years and 6 months)
Duration Of Response(Up to 3 years and 6 months)
Number Of Participants Experiencing Treatment -Emergent Adverse Events (AEs)(From the initiation of study drug until 30 days after the last dose (Up to 3 years and 6 months))
Progression-free Survival(Up to 3 years and 6 months)