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

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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