Trial · NCT03520920
BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)
NCT03520920, Phase 2, Completed, BeiGene; results first posted 2021-10-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL). Trials, record NCT03520920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03520920
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)
- NCT number
- NCT03520920
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Marginal Zone Lymphoma, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
- Interventions
- Zanubrutinib, Rituximab
- First posted
- 2018-05-11
- Last updated
- 2024-10-26
- Results first posted
- 2021-10-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) As Measured By The Investigator | Up to approximately 2.5 years | 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. |
| Secondary | Duration Of Response (DOR) As Determined By Investigator | Up to approximately 2.5 years | 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. |
| Secondary | DOR: Event-free Rate | Up to approximately 2.5 years | 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. |
| Secondary | Progression-free Survival (PFS) As Determined By Investigator | Up to approximately 2.5 years | 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. |
| Secondary | PFS: Event-free Rate | Up to approximately 2.5 years | 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. |
| Secondary | Overall Survival (OS) | Up to approximately 2.5 years | 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. |
| Secondary | OS: Survival Rate | Up to approximately 2.5 years | 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. |
| Secondary | Time To Response (TTR) As Determined By The Investigator | Up to approximately 2.5 years | 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). |
| Secondary | Median TTR | Up to approximately 2.5 years | 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). |
| Secondary | Complete Response Rate As Determined By The Investigator | Up to approximately 2.5 years | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) As Measured By The Investigator | Up to approximately 2.5 years | Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab) on the study. | Percentage of Participants | NUMBER |
| SECONDARY | Duration Of Response (DOR) As Determined By Investigator | Up to approximately 2.5 years | 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. | Months | MEDIAN |
| SECONDARY | DOR: Event-free Rate | Up to approximately 2.5 years | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Percentage of Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) As Determined By Investigator | Up to approximately 2.5 years | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Months | MEDIAN |
| SECONDARY | PFS: Event-free Rate | Up to approximately 2.5 years | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to approximately 2.5 years | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Months | MEDIAN |
| SECONDARY | OS: Survival Rate | Up to approximately 2.5 years | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Percentage of Participants | NUMBER |
| SECONDARY | Time To Response (TTR) As Determined By The Investigator | Up to approximately 2.5 years | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Months | MEAN |
| SECONDARY | Median TTR | Up to approximately 2.5 years | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Months | MEDIAN |
| SECONDARY | Complete Response Rate As Determined By The Investigator | Up to approximately 2.5 years | The Safety Analysis Set included all participants who received at least 1 dose of study drug (zanubrutinib or rituximab). | Percentage of Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group81
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) As Measured By The Investigator | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 35 | 95% Confidence Interval 15.4 to 59.2 | Percentage of Participants | |
| Overall Response Rate (ORR) As Measured By The Investigator | Relapsed/Refractory Follicular Lymphoma | 56.3 | 95% Confidence Interval 29.9 to 80.2 | Percentage of Participants | |
| Overall Response Rate (ORR) As Measured By The Investigator | Relapsed/Refractory Marginal Zone Lymphoma | 60.0 | 95% Confidence Interval 14.7 to 94.7 | Percentage of Participants | |
| Duration Of Response (DOR) As Determined By Investigator | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 8.79 | 95% Confidence Interval 0.72 to NA | Months | |
| Duration Of Response (DOR) As Determined By Investigator | Relapsed/Refractory Follicular Lymphoma | NA | 95% Confidence Interval 5.45 to NA | Months | |
| Duration Of Response (DOR) As Determined By Investigator | Relapsed/Refractory Marginal Zone Lymphoma | 22.18 | 95% Confidence Interval 8.31 to NA | Months | |
| DOR: Event-free Rate | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 6 months | 50.0 | 95% Confidence Interval 11.1 to 80.4 | Percentage of Participants |
| DOR: Event-free Rate | Relapsed/Refractory Follicular Lymphoma | 6 months | 88.9 | 95% Confidence Interval 43.3 to 98.4 | Percentage of Participants |
| DOR: Event-free Rate | Relapsed/Refractory Marginal Zone Lymphoma | 6 months | 100.0 | 95% Confidence Interval NA to NA | Percentage of Participants |
| DOR: Event-free Rate | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 9 months | 50.0 | 95% Confidence Interval 11.1 to 80.4 | Percentage of Participants |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 20 | |
| Overall Study | STARTED | Relapsed/Refractory Follicular Lymphoma | 16 | |
| Overall Study | STARTED | Relapsed/Refractory Marginal Zone Lymphoma | 5 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 20 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Relapsed/Refractory Follicular Lymphoma | 16 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Relapsed/Refractory Marginal Zone Lymphoma | 5 | |
| Overall Study | COMPLETED | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 0 | |
| Overall Study | COMPLETED | Relapsed/Refractory Follicular Lymphoma | 0 | |
| Overall Study | COMPLETED | Relapsed/Refractory Marginal Zone Lymphoma | 0 | |
| Overall Study | NOT COMPLETED | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events156
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | White blood cell count decreased | Investigations | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 5 | 20 | |
| other | White blood cell count decreased | Investigations | Relapsed/Refractory Follicular Lymphoma | 5 | 16 | |
| other | White blood cell count decreased | Investigations | Relapsed/Refractory Marginal Zone Lymphoma | 3 | 5 | |
| other | Neutrophil count decreased | Investigations | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 4 | 20 | |
| other | Neutrophil count decreased | Investigations | Relapsed/Refractory Follicular Lymphoma | 4 | 16 | |
| other | Neutrophil count decreased | Investigations | Relapsed/Refractory Marginal Zone Lymphoma | 3 | 5 | |
| other | Alanine aminotransferase increased | Investigations | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 3 | 20 | |
| other | Alanine aminotransferase increased | Investigations | Relapsed/Refractory Follicular Lymphoma | 2 | 16 | |
| other | Alanine aminotransferase increased | Investigations | Relapsed/Refractory Marginal Zone Lymphoma | 1 | 5 | |
| other | Aspartate aminotransferase increased | Investigations | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 2 | 20 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 13 | 20 |
| Total, all-cause mortality | Relapsed/Refractory Follicular Lymphoma | 1 | 16 |
| Total, all-cause mortality | Relapsed/Refractory Marginal Zone Lymphoma | 0 | 5 |
| Total, other adverse events | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 19 | 20 |
| Total, other adverse events | Relapsed/Refractory Follicular Lymphoma | 16 | 16 |
| Total, other adverse events | Relapsed/Refractory Marginal Zone Lymphoma | 5 | 5 |
| Total, serious adverse events | Relapsed/Refractory Non-germinal Center B-cell-like Diffuse Large B-cell Lymphoma | 7 | 20 |
| Total, serious adverse events | Relapsed/Refractory Follicular Lymphoma | 4 | 16 |
| Total, serious adverse events | Relapsed/Refractory Marginal Zone Lymphoma | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38775302 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03520920
GET https://conductscience.org/api/trials/v1/NCT03520920/results?page=2