Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

NCT03206970 | Completed Phase 2 Results DMC

• 2 other identifiers: BGB-3111-206CTR20160888
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 13

Brief Summary

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

Conditions

Refractory Mantle Cell Lymphoma; Relapsed Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 1 year and 11 months

Secondary Outcomes (6)

• Progression-free Survival

  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

• ORR As Assessed By The Investigator

  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)

Study Arms (1)

Zanubrutinib

EXPERIMENTAL

Zanubrutinib (160 milligrams) administered orally twice daily

Drug: Zanubrutinib

Interventions

Zanubrutinib DRUG

Administered as specified in the treatment arm.

Also known as: BGB-3111

Zanubrutinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic report had to include evidence for morphological and cyclin D1 or t (11; 14).
• Eastern Cooperative Oncology Group performance status of 0-2.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• BeiGene: lead

Study Sites (13)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, 300020, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (5)

• Yuqin Song, Keshu Zhou, Dehui Zou, Jianfeng Zhou, Jianda Hu, Haiyan Yang, Huilai Zhang, Jie Ji, Wei Xu, Jie Jin, Fangfang Lv, Ru Feng, Sujun Gao, Daobin Zhou, Haiyi Guo, Aihua Wang, James Hilger, Jane Huang, William Novotny, Muhtar Osman, Jun Zhu; Safety and Activity of the Investigational Bruton Tyrosine Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Mantle Cell Lymphoma from a Phase 2 Trial. Blood 2018; 132 (Supplement 1): 148. doi: https://doi.org/10.1182/blood-2018-99-117956

  RESULT

• Song Y, Zhou K, Zou D, Zhou J, Hu J, Yang H, Zhang H, Ji J, Xu W, Jin J, Lv F, Feng R, Gao S, Guo H, Zhou L, Elstrom R, Huang J, Novotny W, Wei R, Zhu J. Treatment of Patients with Relapsed or Refractory Mantle-Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase. Clin Cancer Res. 2020 Aug 15;26(16):4216-4224. doi: 10.1158/1078-0432.CCR-19-3703. Epub 2020 May 27.

  PMID: 32461234 RESULT

• Tam CS, Opat S, Simpson D, Cull G, Munoz J, Phillips TJ, Kim WS, Rule S, Atwal SK, Wei R, Novotny W, Huang J, Wang M, Trotman J. Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma. Blood Adv. 2021 Jun 22;5(12):2577-2585. doi: 10.1182/bloodadvances.2020004074.

  PMID: 34152395 RESULT

• Moslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641.

  PMID: 38502198 DERIVED

• Song Y, Zhou K, Zou D, Zhou J, Hu J, Yang H, Zhang H, Ji J, Xu W, Jin J, Lv F, Feng R, Gao S, Guo H, Zhou L, Huang J, Novotny W, Kim P, Yu Y, Wu B, Zhu J. Zanubrutinib in relapsed/refractory mantle cell lymphoma: long-term efficacy and safety results from a phase 2 study. Blood. 2022 May 26;139(21):3148-3158. doi: 10.1182/blood.2021014162.

  PMID: 35303070 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2017
• First Posted: July 2, 2017
• Study Start: March 2, 2017
• Primary Completion: February 15, 2019
• Study Completion: September 8, 2020
• Last Updated: October 26, 2024
• Results First Posted: May 13, 2020

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (13)