Trial · NCT03734016
A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
NCT03734016, Phase 3, Completed, BeiGene; results first posted 2023-07-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia. Trials, record NCT03734016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03734016
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia
- NCT number
- NCT03734016
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 652 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Interventions
- Zanubrutinib, Ibrutinib
- First posted
- 2018-11-07
- Last updated
- 2025-03-30
- Other registries' IDs
- eudract:2018-001366-42
- Results first posted
- 2023-07-27
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) Assessed by the Investigator | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) per investigator assessment. Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL. |
| Primary | ORR Assessed by the Independent Review Committee (IRC) | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | ORR is defined as the percentage of participants with a complete response (CR) / complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) assessed by a blinded independent review committee. Overall response was assessed by the IRC for the purpose of regulatory filing with the Food and Drug Administration (FDA). Disease response was assessed in accordance with the 2008 criteria of the International Workshop on CLL (IWCLL), with modification for treatment-related lymphocytosis in participants with CLL and in accordance with the Lugano classification in participants with SLL. |
| Secondary | Progression-free Survival (PFS) Assessed by the Investigator | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Progression-free Survival Assessed by the Independent Review Committee | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Atrial Fibrillation or Atrial Flutter | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | Participants were considered as having an atrial fibrillation/flutter event if they had a treatment-emergent AE of either "atrial fibrillation" or "atrial flutter". |
| Secondary | Duration of Response Assessed by the Independent Review Committee | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by independent central review. Median DOR was estimated using the Kaplan-Meier method. |
| Secondary | Duration of Response (DOR) Assessed by the Investigator | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | DOR is defined as the time from the date that response criteria were first met to the date that disease progression was objectively documented or death, whichever occurred first, determined by investigator assessment. Median DOR was estimated using the Kaplan-Meier method. |
| Secondary | Time to Treatment Failure | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | Time to treatment failure is defined as the time from randomization to discontinuation of study drug due to any reason. Median time to treatment failure was estimated by the Kaplan-Meier method. |
| Secondary | Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Independent Review Committee | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | The rate of partial response with lymphocytosis or better is defined as the percentage of participants who achieved a complete response or a complete response with incomplete bone marrow recovery (CR/CRi), nodular partial response, partial response, or partial response with lymphocytosis assessed by the blinded IRC. Disease response was assessed per iwCLL 2008 criteria, with modification for treatment-related lymphocytosis for participants with CLL and per Lugano classification for participants with SLL. |
| Secondary | Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Investigator | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | The rate of partial response with lymphocytosis or better is defined as the percentage of participants who achieved a complete response or complete response with incomplete bone marrow recovery (CR/CRi), nodular partial response, partial response, or partial response with lymphocytosis as assessed by the investigator. Disease response was assessed according to the iwCLL 2008 criteria, with modification for treatment-related lymphocytosis for participants with CLL and in accordance with Lugano classification for participants with SLL. Partial response with lymphocytosis: blood lymphocytes decreased \< 50% or increased from baseline, and otherwise meeting criteria for PR. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
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) Assessed by the Investigator | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | Intent To Treat (ITT) Analysis Set | percentage of participants | NUMBER |
| PRIMARY | ORR Assessed by the Independent Review Committee (IRC) | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | ITT Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) Assessed by the Investigator | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | ITT Analysis Set | months | MEDIAN |
| SECONDARY | Progression-free Survival Assessed by the Independent Review Committee | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | Intent To Treat Analysis Set | months | MEDIAN |
| SECONDARY | Percentage of Participants With Atrial Fibrillation or Atrial Flutter | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | The Safety Analysis Set includes all participants who received any dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response Assessed by the Independent Review Committee | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | Participants in the ITT Analysis Set with an objective response assessed by the IRC | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Assessed by the Investigator | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | Participants in the ITT Analysis Set with an objective response as assessed by the investigator | months | MEDIAN |
| SECONDARY | Time to Treatment Failure | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | ITT Analysis Set | months | MEDIAN |
| SECONDARY | Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Independent Review Committee | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | ITT Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Rate of Partial Response With Lymphocytosis (PR-L) or Higher Assessed by the Investigator | From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months). | ITT Analysis Set | percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group58
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) Assessed by the Investigator | Zanubrutinib | 83.5 | 95% Confidence Interval 79.0 to 87.3 | percentage of participants | |
| Overall Response Rate (ORR) Assessed by the Investigator | Ibrutinib | 74.2 | 95% Confidence Interval 69.0 to 78.8 | percentage of participants | |
| ORR Assessed by the Independent Review Committee (IRC) | Zanubrutinib | 86.2 | 95% Confidence Interval 82.0 to 89.8 | percentage of participants | |
| ORR Assessed by the Independent Review Committee (IRC) | Ibrutinib | 75.7 | 95% Confidence Interval 70.7 to 80.3 | percentage of participants | |
| Progression-free Survival (PFS) Assessed by the Investigator | Zanubrutinib | NA | 95% Confidence Interval 34.3 to NA | months | |
| Progression-free Survival (PFS) Assessed by the Investigator | Ibrutinib | 34.2 | 95% Confidence Interval 33.3 to NA | months | |
| Progression-free Survival Assessed by the Independent Review Committee | Zanubrutinib | NA | 95% Confidence Interval 34.3 to NA | months | |
| Progression-free Survival Assessed by the Independent Review Committee | Ibrutinib | 35.0 | 95% Confidence Interval 33.2 to 44.3 | months | |
| Percentage of Participants With Atrial Fibrillation or Atrial Flutter | Zanubrutinib | 5.2 | 95% Confidence Interval 3.1 to 8.3 | percentage of participants | |
| Percentage of Participants With Atrial Fibrillation or Atrial Flutter | Ibrutinib | 13.3 | 95% Confidence Interval 9.8 to 17.5 | percentage of participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zanubrutinib | 327 | |
| Overall Study | STARTED | Ibrutinib | 325 | |
| Overall Study | Received Study Drug | Zanubrutinib | 324 | |
| Overall Study | Received Study Drug | Ibrutinib | 324 | |
| Overall Study | COMPLETED | Zanubrutinib | 0 | |
| Overall Study | COMPLETED | Ibrutinib | 0 | |
| Overall Study | NOT COMPLETED | Zanubrutinib | 327 | |
| Overall Study | NOT COMPLETED | Ibrutinib | 325 |
Source ClinicalTrials.gov
Adverse events800
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 | Anaemia | Blood and lymphatic system disorders | Zanubrutinib | 53 | 324 | 82 |
| other | Anaemia | Blood and lymphatic system disorders | Ibrutinib | 56 | 324 | 122 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Zanubrutinib | 6 | 324 | 10 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Ibrutinib | 11 | 324 | 13 |
| other | Neutropenia | Blood and lymphatic system disorders | Zanubrutinib | 81 | 324 | 195 |
| other | Neutropenia | Blood and lymphatic system disorders | Ibrutinib | 73 | 324 | 162 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Zanubrutinib | 34 | 324 | 90 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ibrutinib | 35 | 324 | 92 |
| other | Atrial fibrillation | Cardiac disorders | Zanubrutinib | 22 | 324 | 27 |
| other | Atrial fibrillation | Cardiac disorders | Ibrutinib | 45 | 324 | 69 |
1 to 10 of 800Source ClinicalTrials.gov
See all 800 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zanubrutinib | 69 | 327 |
| Total, all-cause mortality | Ibrutinib | 83 | 325 |
| Total, other adverse events | Zanubrutinib | 310 | 324 |
| Total, other adverse events | Ibrutinib | 314 | 324 |
| Total, serious adverse events | Zanubrutinib | 172 | 324 |
| Total, serious adverse events | Ibrutinib | 196 | 324 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zanubrutinib vs Ibrutinib: deaths from any cause | Trial comparisons |
| Zanubrutinib vs Ibrutinib: serious adverse events | Trial comparisons |
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.
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