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BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)

A Phase 2 Study to Assess the Safety, Tolerability, and Activity of BGB-3111 in Combination With Rituximab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (Non-GCB Subtype) and Relapsed/Refractory Indolent Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)

NCT03520920•BeiGene

View on ClinicalTrials.gov

Summary

This was a multicenter, open-label, phase 2 study to evaluate efficacy, safety, and tolerability of BGB-3111 (zanubrutinib) 160 milligrams (mg) twice daily (BID) in combination with rituximab in Chinese participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) (non-GCB \[non-germinal center B-cell-like\] subtype) and R/R indolent lymphoma (follicular lymphoma \[FL\] and marginal zone lymphoma \[MZL\]).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥ Age 18 years at time of signing of informed consent.
•2. Measurable disease by computed tomography (CT) or positron emission tomography/CT or magnetic resonance imaging, defined as ≥1 nodal lesion that was \>1.5 centimeters (cm) in the longest diameter, or ≥1 extra-nodal lesion (for example, hepatic nodules) that was \>1 cm in the longest diameter.
•3. Availability of archival or fresh tumor tissue sample from an evaluable core or excisional biopsy.
•4. Participants meet the following criteria:
•1. Cohort 1: R/R non-GCB DLBCL i. Histologically confirmed non-GCB DLBCL per Hans criteria with non-transformed disease; additional methodologies for confirming non-GCB DLBCL may have been considered in consultation with the medical monitor. ii. Relapsed disease (disease progression after most recent therapy for DLBCL occurring more than 6 months after the completion of last therapy) or refractory disease (failure to achieve complete response \[CR\] or partial response \[PR\] to therapy for non-GCB DLBCL or disease progression within 6 months after completion of the most recent therapy for non-GCB DLBCL). iii. Must have received at least one standard anthracycline ± rituximab-based treatment (for example, rituximab plus cyclophosphamide, doxorubicin \[or epirubicin, hydroxydaunorubicin, or similar\], vincristine, and prednisone) or cyclophosphamide, vincristine, and prednisone +/- rituximab for DLBCL.
•2. Cohort 2: R/R FL or R/R MZL i. Histologically confirmed CD20+ FL (Grade 1, 2, or 3a) or MZL. ii. Relapsed disease (disease progression after most recent therapy for FL or MZL occurring more than 6 months after the completion of last therapy) or refractory disease (failure to achieve complete response (CR) or partial response (PR) to most recent therapy for FL or MZL, or disease progression within 6 months after completion of the most recent therapy for FL or MZL).
•5. Laboratory parameters as specified below:
•1. Hematologic: Platelet count ≥75 x 10\^9/liter (L) independent of growth factor or transfusion within 7 days of study entry; absolute neutrophil count (ANC) ≥1 x 10\^9/L independent of growth factor within 7 days of study entry, hemoglobin \>8 grams/deciliter within 7 days of study entry.
•2. Hepatic: Total bilirubin ≤ 2x upper limit of normal (ULN) unless documented Gilbert's syndrome; aspartate aminotransferase/serum glutamic-oxaloacetic transaminase and alanine transaminase/serum glutamic-pyruvic transaminase ≤3x ULN.
•3. Renal: Creatinine clearance ≥30 milliliters/minute (as estimated by the Cockcroft-Gault equation based on ideal body weight or as measured by nuclear medicine scan or 24-hour urine collection).
+9 more criteria

Exclusion Criteria

•1. Known central nervous system lymphoma or leukemia.
•2. Histological confirmed gastric mucosa-associated lymphoid tissue type MZL.
•3. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
•4. Clinically significant cardiovascular disease.
•5. History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.
•6. History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
•7. Severe or debilitating pulmonary disease.
•8. Hypersensitivity reaction to zanubrutinib or rituximab or any of the other ingredients of the study drugs.
•9. Prior Bruton tyrosine kinase inhibitor treatment.
•10. Required ongoing treatment with a strong cytochrome P450 protein inhibitor or inducer.
+14 more criteria

Locations (4)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

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

Wuhan, Hubei, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 4, 2018

Primary Completion Date

August 28, 2020

Completion Date

August 28, 2020

Last Updated

October 26, 2024

Enrollment

ACTUAL participants

Conditions

Marginal Zone LymphomaFollicular LymphomaDiffuse Large B-Cell Lymphoma

Interventions

Zanubrutinib

DRUG

Rituximab

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE3

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

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Odronextamab in Low Tumor Volume Advanced FL

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy