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

Sponsor
BeiGene
Study ID
NCT03520920
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    Administered zanubrutinib 160 mg orally (PO) BID continuously
  • Rituximab — DRUG
    Administered rituximab 375 mg/m\^2 intravenously on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.

Study Details

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 \[MZL\]).

Key Dates

First listed
May 11, 2018
Start date
Jan 4, 2018
Status verified
Oct 2024
Primary completion
Aug 28, 2020
Completion
Aug 28, 2020

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: R/R Non-GCB DLBCL
    Participants with non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
  • Experimental: R/R FL or MZL
    Participants with R/R FL or MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.

Primary Outcome Measure

Overall Response Rate (ORR) As Measured By The Investigator [ Time Frame: Up to approximately 2.5 years ]

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