NCT03145064

Brief Summary

Screening (up to 28 days); daily treatment until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow-up, or study termination from sponsor; treatment (up to 2 years), safety follow-up (30 days); survival follow-up until data cutoff for final analysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2017

Typical duration for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 8, 2021

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

May 5, 2017

Results QC Date

August 31, 2021

Last Update Submit

October 23, 2024

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Relapsed/refractory non-GCB type

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Overall response rate was defined as the percentage of participants achieving either a partial response (PR) or complete response (CR) as determined by investigator according to the 2014 modification of the International Working Group (IWG) in Non-Hodgkin's lymphoma (NHL) Criteria.

    Up to approximately 23 months

Secondary Outcomes (4)

  • Progression-free Survival

    Up to 3 years and 2 months

  • Duration Of Response

    Up to 3 years and 2 months

  • Time To Response

    Up to 3 years and 2 months

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    From the time of informed consent to 30 days after the last dose of study drug (approximately Up to 3 years and 2 months)

Other Outcomes (1)

  • Overall Survival

    Up to 3 years and 2 months

Study Arms (1)

Zanubrutinib

EXPERIMENTAL

Participants received zanubrutinib BID.

Drug: Zanubrutinib

Interventions

ZanubrutinibDRUG

Administered at a dose of 160 mg BID orally.

Also known as: BGB-3111, BRUKINSA
Zanubrutinib

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsmale and female
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-germinal center DLBCL, by immunohistochemistry using the Hans algorithm:
  • Cluster of differentiation 10 (CD10)- and B-cell lymphoma 6 protein (BCL6)-,
  • CD10-, BCL6+, but maximal unique match+
  • Men and women ≥ 18 years of age.
  • Eastern Cooperative Oncology Group performance status of 0-2.
  • Measurable disease was defined as at least 1 lymph node \> 1.5 centimeters in longest diameter and measurable in 2 perpendicular dimensions.
  • All participants must have provided fresh tumor biopsy or recent tumor tissue samples (within 2 years of study entry \[informed consent form signed\]).
  • Received at least one prior therapy for DLBCL that included anthracycline-based chemotherapy.
  • Participant not eligible for or refused intensive chemotherapy and hematopoietic stem cell transplant.
  • Documented failure to achieve at least partial response with, or documented disease progression after response to, the most recent treatment regimen.
  • Neutrophils ≥ 1 x 10\^9/liter (L) independent of growth factor support within 7 days of study entry.
  • Platelets ≥ 75 x 10\^9/L, independent of growth factor support or transfusion within 7 days of study entry.
  • Creatinine clearance of ≥ 30 milliliters/minute (as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate).
  • Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN).
  • Bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome), then up to 5 x ULN allowed.
  • +6 more criteria

You may not qualify if:

  • Current or history of central nervous system lymphoma.
  • Prior exposure to a BTK inhibitor.
  • Prior corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks, or antibody-based therapies or Chinese anti-cancer herbal therapies within 4 weeks of the start of study drug.
  • Major surgery within 4 weeks of screening.
  • History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
  • Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or history of myocardial infarction within 6 months of screening. Left ventricular ejection fraction is lower than 50% measured by echocardiography.
  • QTcF (Fridericia's correction) \> 450 milliseconds or other significant electrocardiogram abnormalities including second degree atrioventricular (AV) block Type II, or third-degree AV block.
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy.
  • Known human immunodeficiency virus, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction).
  • Pregnant or lactating women.
  • Any life-threatening illness, medical condition or organ system dysfunction, which, in the investigator's opinion, could compromise the participant's safety, or put the study at risk.
  • On medications that were strong cytochrome P450 (CYP), family 3, subfamily A (CYP3A) inhibitors or CYP3A inducers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Soochow University Branch Shizi

Suzhou, Jiangsu, 215006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, 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

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

  • Yang H, Xiang B, Song Y, Zhang H, Zhao W, Zou D, Lv F, Bai O, Liu A, Li C, Tan Z, Wang W, Gui H, Novotny W, Huang J, Li Y. Zanubrutinib monotherapy for patients with relapsed or refractory non-germinal center diffuse large B-cell lymphoma: results from a phase II, single-arm, multicenter, study. American Society of Clinical Oncology. 2020

    BACKGROUND

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseRecurrence

Interventions

zanubrutinib

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 9, 2017

Study Start

June 30, 2017

Primary Completion

May 24, 2019

Study Completion

September 3, 2020

Last Updated

October 26, 2024

Results First Posted

November 8, 2021

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

Locations

CN(11)