Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Waldenstrom Macroglobulinemia

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Zanubrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity

Study Director

This was a single-arm, multicenter Phase 2 study in Chinese participants with relapsed or refractory Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the Seventh International Workshop on Waldenström's Macroglobulinemia (IWWM). The study comprised an initial screening phase (up to 28 days), a single-arm treatment phase, and a follow-up phase.

Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

A Phase 2, Single-Arm, Open-Label, Multicenter Study of Bruton's Tyrosine Kinase (BTK) Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by an independent review committee according to modified Owen's criteria

PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria

Progression/death event-free rates were estimated by Kaplan-Meier method with 95% confidence intervals (CIs) estimated using Greenwood's formula

ORR is defined as the percentage of participants with a minor, partial, very good partial, and complete response, as assessed by an independent review committee using modified Owen's criteria

DOMR is defined as the time from the date that the major response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria

DOMR event-free rates were estimated by Kaplan-Meier method with 95% CIs estimated using Greenwood's formula

Number of participants with resolution of treatment-precipitating symptoms, defined as any resolution (from "Yes" at baseline to "No" at any postbaseline point onwards during study) of the indications for initiation of therapy in WM signs and symptoms evaluation.

Number of participants with an anti-lymphoma effect, defined as any reduction during the course of study in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by computed tomography scan as assessed by an independent review committee; lymphadenopathy is defined as any node with longest diameter (LDi) \> 1.5 cm and splenomegaly is defined as vertical spleen length \> 13 cm

Number of participants with treatment-emergent adverse events (TEAEs), grade 3 or higher TEAEs, serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest, and TEAEs leading to study drug discontinuation, dose reduction and treatment interruption

BeiGene

A treatment-emergent adverse event (TEAE) was defined as an adverse event that had an onset or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after the last dose of study drug or initiation of new anticancer therapy, whichever occurred first. Worsening of an event to Grade 5 beyond 30 days after the last dose of study drug was also considered a TEAE (if prior to start of new anticancer therapy).

Age, Continuous

Sex: Female, Male

Chinese

Race/Ethnicity, Customized

Zanubrutinib versus historical control estimate of 30%

Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L

Major Response Rate (MRR) as Assessed by the Independent Review Committee

Progression Free Survival (PFS)

6 months

9 months

12 months

PFS: Event-free Rate

Overall Response Rate (ORR)

Duration of Major Response (DOMR)

DOMR: Event-free Rate

Number of Participants With Resolution of Treatment-precipitating Symptoms

Number of Participants With an Anti-lymphoma Effect

At least one TEAE

Grade 3 or higher TEAEs

Serious TEAEs

Treatment-related TEAEs

TEAEs of special interest

TEAEs leading to study drug discontinuation

TEAEs leading to treatment interruption

TEAEs leading to dose reduction

The Safety Analysis Set included all participants who received ≥ 1 dose of study drug

Spots Global Cancer Trial Database for Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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