Trial Outcomes & Findings for BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL) (NCT NCT03520920)
NCT ID: NCT03520920
Last Updated: 2024-10-26
Results Overview
The percentage of participants whose best overall response met partial response (PR) or complete response (CR) criteria among all participants. The 95% confidence interval (CI) was calculated with the Clopper-Pearson method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to approximately 2.5 years
Results posted on
2024-10-26
Participant Flow
This study was conducted at 4 study centers in China, all of which enrolled participants. The first enrolled participants received their first dose on 04 January 2018, and the last participant enrolled received their first dose on 20 December 2018. A total of 41 participants with non-Hodgkin lymphoma (NHL) were enrolled into the study, and all received ≥1 dose of study treatment.
Participant milestones
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
Participants with relapsed/refractory (R/R) non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 milligrams (mg) orally (PO) twice daily (BID) continuously and rituximab 375 mg/meter squared (m\^2) intravenously (IV) on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
Relapsed/Refractory Follicular Lymphoma
Participants with R/R follicular lymphoma (FL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
Relapsed/Refractory Marginal Zone Lymphoma
Participants with R/R marginal zone lymphoma (MZL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
16
|
5
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
20
|
16
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
5
|
Reasons for withdrawal
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
Participants with relapsed/refractory (R/R) non-germinal center B-cell-like diffuse large B-cell lymphoma (non-GCB DLBCL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 milligrams (mg) orally (PO) twice daily (BID) continuously and rituximab 375 mg/meter squared (m\^2) intravenously (IV) on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
Relapsed/Refractory Follicular Lymphoma
Participants with R/R follicular lymphoma (FL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
Relapsed/Refractory Marginal Zone Lymphoma
Participants with R/R marginal zone lymphoma (MZL) received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
|---|---|---|---|
|
Overall Study
Death
|
13
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Study Terminated by the Sponsor
|
5
|
14
|
5
|
Baseline Characteristics
BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)
Baseline characteristics by cohort
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and rituximab 375 mg/m\^2 IV on Cycle 1 Days 1, 8, 15, 22, and on Day 1 of Cycles 4, 6, 8, 10. Each cycle was 28 days long.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.2 years
STANDARD_DEVIATION 15.00 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 12.36 • n=7 Participants
|
61.2 years
STANDARD_DEVIATION 8.87 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 13.94 • n=4 Participants
|
|
Age, Customized
<65 years
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Body Mass Index
|
23.43 kilogram/m^2
STANDARD_DEVIATION 2.652 • n=5 Participants
|
25.04 kilogram/m^2
STANDARD_DEVIATION 5.079 • n=7 Participants
|
24.33 kilogram/m^2
STANDARD_DEVIATION 4.813 • n=5 Participants
|
24.17 kilogram/m^2
STANDARD_DEVIATION 3.989 • n=4 Participants
|
|
Body Surface Area
|
1.72 m^2
STANDARD_DEVIATION 0.113 • n=5 Participants
|
1.77 m^2
STANDARD_DEVIATION 0.295 • n=7 Participants
|
1.69 m^2
STANDARD_DEVIATION 0.240 • n=5 Participants
|
1.74 m^2
STANDARD_DEVIATION 0.213 • n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance (ECOG)Status
Grade 0
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance (ECOG)Status
Grade 1
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group Performance (ECOG)Status
Grade 2
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Hepatitis B Core Antibody
Positive
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Hepatitis B Core Antibody
Negative
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Hepatitis B Core Antibody
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab) on the study.
The percentage of participants whose best overall response met partial response (PR) or complete response (CR) criteria among all participants. The 95% confidence interval (CI) was calculated with the Clopper-Pearson method.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
Overall Response Rate (ORR) As Measured By The Investigator
|
35 Percentage of Participants
Interval 15.4 to 59.2
|
56.3 Percentage of Participants
Interval 29.9 to 80.2
|
60.0 Percentage of Participants
Interval 14.7 to 94.7
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab) on the study. Duration of response was summarized for responders (participants with a best response of partial response or higher) only.
The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=7 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=9 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=3 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
Duration Of Response (DOR) As Determined By Investigator
|
8.79 Months
Interval 0.72 to
NA = Not estimable due to insufficient number of participants with events
|
NA Months
Interval 5.45 to
NA = Not estimable due to insufficient number of participants with events
|
22.18 Months
Interval 8.31 to
NA = Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
The DOR was defined as the time from the date that the response criteria were first met to the date that progressive disease (PD) was objectively documented or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
DOR: Event-free Rate
15 months
|
33.3 Percentage of Participants
Interval 4.6 to 67.6
|
51.9 Percentage of Participants
Interval 16.4 to 78.8
|
66.7 Percentage of Participants
Interval 5.4 to 94.5
|
|
DOR: Event-free Rate
18 months
|
33.3 Percentage of Participants
Interval 4.6 to 67.6
|
51.9 Percentage of Participants
Interval 16.4 to 78.8
|
66.7 Percentage of Participants
Interval 5.4 to 94.5
|
|
DOR: Event-free Rate
6 months
|
50.0 Percentage of Participants
Interval 11.1 to 80.4
|
88.9 Percentage of Participants
Interval 43.3 to 98.4
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
|
DOR: Event-free Rate
9 months
|
50.0 Percentage of Participants
Interval 11.1 to 80.4
|
77.8 Percentage of Participants
Interval 36.5 to 93.9
|
66.7 Percentage of Participants
Interval 5.4 to 94.5
|
|
DOR: Event-free Rate
12 months
|
50.0 Percentage of Participants
Interval 11.1 to 80.4
|
64.8 Percentage of Participants
Interval 25.3 to 87.2
|
66.7 Percentage of Participants
Interval 5.4 to 94.5
|
|
DOR: Event-free Rate
24 months
|
NA Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
NA Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
33.3 Percentage of Participants
Interval 0.9 to 77.4
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the Brookmeyer and Crowley method.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
Progression-free Survival (PFS) As Determined By Investigator
|
3.38 Months
Interval 2.69 to 5.49
|
11.10 Months
Interval 5.49 to
NA = Not estimable due to insufficient number of participants with events
|
24.87 Months
Interval 11.01 to
NA = Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
The PFS was defined as time from first dose of study treatment until first documentation of progression, assessed per the Lugano Classification, or death, whichever occurred first. The event-free rate was estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
PFS: Event-free Rate
9 months
|
17.4 Percentage of Participants
Interval 4.3 to 37.7
|
66.7 Percentage of Participants
Interval 37.5 to 84.6
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
|
PFS: Event-free Rate
24 months
|
11.6 Percentage of Participants
Interval 2.0 to 30.7
|
40.0 Percentage of Participants
Interval 16.5 to 62.8
|
60.0 Percentage of Participants
Interval 12.6 to 88.2
|
|
PFS: Event-free Rate
6 months
|
17.4 Percentage of Participants
Interval 4.3 to 37.7
|
73.3 Percentage of Participants
Interval 43.3 to 89.1
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
|
PFS: Event-free Rate
12 months
|
17.4 Percentage of Participants
Interval 4.3 to 37.7
|
46.7 Percentage of Participants
Interval 21.2 to 68.7
|
80.0 Percentage of Participants
Interval 20.4 to 96.9
|
|
PFS: Event-free Rate
15 months
|
17.4 Percentage of Participants
Interval 4.3 to 37.7
|
46.7 Percentage of Participants
Interval 21.2 to 68.7
|
60.0 Percentage of Participants
Interval 12.6 to 88.2
|
|
PFS: Event-free Rate
18 months
|
11.6 Percentage of Participants
Interval 2.0 to 30.7
|
40.0 Percentage of Participants
Interval 16.5 to 62.8
|
60.0 Percentage of Participants
Interval 12.6 to 88.2
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Medians were estimated by the Kaplan-Meier method with 95% CIs estimated using the method of Brookmeyer and Crowley.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
Overall Survival (OS)
|
11.20 Months
Interval 5.39 to 24.44
|
NA Months
NA = Not estimable due to insufficient number of participants with events
|
NA Months
NA = Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
The OS was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Survival rates were estimated by the Kaplan-Meier method with 95% CIs estimated using Greenwood's formula.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
OS: Survival Rate
15 months
|
33.6 Percentage of Participants
Interval 13.8 to 54.8
|
93.3 Percentage of Participants
Interval 61.3 to 99.0
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
|
OS: Survival Rate
24 months
|
33.6 Percentage of Participants
Interval 13.8 to 54.8
|
93.3 Percentage of Participants
Interval 61.3 to 99.0
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
|
OS: Survival Rate
6 months
|
72.7 Percentage of Participants
Interval 46.3 to 87.6
|
93.3 Percentage of Participants
Interval 61.3 to 99.0
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
|
OS: Survival Rate
9 months
|
55.9 Percentage of Participants
Interval 30.8 to 75.0
|
93.3 Percentage of Participants
Interval 61.3 to 99.0
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
|
OS: Survival Rate
12 months
|
44.7 Percentage of Participants
Interval 21.8 to 65.4
|
93.3 Percentage of Participants
Interval 61.3 to 99.0
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
|
OS: Survival Rate
18 months
|
33.6 Percentage of Participants
Interval 13.8 to 54.8
|
93.3 Percentage of Participants
Interval 61.3 to 99.0
|
100.0 Percentage of Participants
NA = Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better).
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
Time To Response (TTR) As Determined By The Investigator
|
3.56 Months
Standard Deviation 2.054
|
6.15 Months
Standard Deviation 3.867
|
3.67 Months
Standard Deviation 1.631
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
The TTR was defined as the time from the date of the first dose of study treatment to the date of the first qualifying response (partial response or better).
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
Median TTR
|
2.79 Months
Interval 2.7 to 8.2
|
5.49 Months
Interval 2.6 to 13.8
|
2.73 Months
Interval 2.7 to 5.6
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
The percentage of participants whose best overall response met complete response or complete metabolic response criteria among all participants are reported. The 95% CI was calculated with Clopper-Pearson method.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
Complete Response Rate As Determined By The Investigator
|
10.0 Percentage of Participants
Interval 1.2 to 31.7
|
18.8 Percentage of Participants
Interval 4.0 to 45.6
|
0.0 Percentage of Participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: Up to approximately 2.5 yearsPopulation: The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab).
A treatment-emergent adverse event was defined as an adverse event with an onset or worsening (if present pretreatment) starting on or after the first dose of study drug up to 30 days after discontinuation of zanubrutinib or 90 days after discontinuation of rituximab, whichever occurred later; or initiation of new anticancer therapy if it occurred prior to the other 2 dates. Worsening of a treatment-emergent adverse event to Grade 5 beyond Day 30 after the last dose of zanubrutinib or Day 90 after the last dose rituximab was also considered a treatment-emergent adverse event if the event occurred prior to initiation of new anticancer therapy.
Outcome measures
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 Participants
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Follicular Lymphoma
n=16 Participants
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 Participants
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance. Administered zanubrutinib 160 mg PO BID continuously and 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.
|
|---|---|---|---|
|
Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs
Participants With at Least 1 TEAE
|
20 Participants
|
16 Participants
|
5 Participants
|
|
Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs
Serious TEAEs
|
7 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
Serious events: 7 serious events
Other events: 19 other events
Deaths: 13 deaths
Relapsed/Refractory Follicular Lymphoma
Serious events: 4 serious events
Other events: 16 other events
Deaths: 1 deaths
Relapsed/Refractory Marginal Zone Lymphoma
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 participants at risk
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
|
Relapsed/Refractory Follicular Lymphoma
n=16 participants at risk
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 participants at risk
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Infections and infestations
Lymph gland infection
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
General disorders
Death
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
General disorders
General physical health deterioration
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Psychiatric disorders
Completed suicide
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
Other adverse events
| Measure |
Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma
n=20 participants at risk
Participants with R/R non-GCB DLBCL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
|
Relapsed/Refractory Follicular Lymphoma
n=16 participants at risk
Participants with R/R FL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
|
Relapsed/Refractory Marginal Zone Lymphoma
n=5 participants at risk
Participants with R/R MZL received zanubrutinib plus rituximab for up to progressive disease or intolerance.
|
|---|---|---|---|
|
Investigations
White blood cell count decreased
|
25.0%
5/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
31.2%
5/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
60.0%
3/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Investigations
Neutrophil count decreased
|
20.0%
4/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
25.0%
4/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
60.0%
3/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Investigations
Alanine aminotransferase increased
|
15.0%
3/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
2/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Investigations
Platelet count decreased
|
15.0%
3/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Investigations
Weight decreased
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Investigations
Blood urine present
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
5/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
18.8%
3/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
80.0%
4/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Infections and infestations
Pneumonia
|
10.0%
2/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
40.0%
2/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
4/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
18.8%
3/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
40.0%
2/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
18.8%
3/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
18.8%
3/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
40.0%
2/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
General disorders
Asthenia
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
40.0%
2/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
General disorders
Oedema peripheral
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
18.8%
3/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
2/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
2/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
25.0%
4/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
25.0%
4/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
40.0%
2/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Renal and urinary disorders
Haemoglobinuria
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
12.5%
2/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
0.00%
0/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
6.2%
1/16 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
20.0%
1/5 • Day 1 through approximately 2.5 years
Participants were assessed for adverse events throughput the study and Follow-up Visit (30 days after last dose of zanubrutinib, 90 days after the last dose of rituximab, whichever occurred later). After this period, only new adverse events that were believed to be related to study treatment were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER