Trial · NCT03336333
A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
NCT03336333, Phase 3, Active not recruiting, BeiGene; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL. Trials, record NCT03336333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03336333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Zanubrutinib With Bendamustine Plus Rituximab in Participants With Previously Untreated CLL or SLL
- NCT number
- NCT03336333
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 590 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Interventions
- Zanubrutinib, Bendamustine, Rituximab, Venetoclax
- First posted
- 2017-11-08
- Last updated
- 2026-03-09
- Other registries' IDs
- eudract:2017-001551-31
- Results first posted
- 2023-11-07
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) | Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021) | PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the ICR per 2008 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with small lymphocytic lymphoma (SLL). |
| Secondary | Cohort 1: Overall Response Rate (ORR) Between Treatment Groups as Determined by ICR | Up to 5 years | ORR in Cohort 1 is defined as the percentage of participants who achieve a complete response, complete response with incomplete bone marrow recovery, partial response, or partial response with lymphocytosis, determined by the ICR. |
| Secondary | Pooled Cohort 1/1a: Overall Response Rate (ORR) Between Treatment Groups | Up to 5 years | |
| Secondary | Cohort 1: Overall Survival (OS) Between Treatment Groups as Determined by the ICR | Up to 5 years | OS in Cohort 1 is defined as the time from randomization to the date of death due to any reason. |
| Secondary | Cohort 1: Duration of Response (DOR) Between Treatment Groups as Determined by the ICR | Up to 5 years | Duration of response in Cohort 1 determined using the iwCLL criteria with modification for treatment related lymphocytosis (in participants with CLL) and the Lugano Classification for non-Hodgkin lymphoma (NHL; in participants with SLL), is defined as the time from the date that criteria for response (ie, partial response with lymphocytosis \[PR-L\] or better) are first met to the date that disease progression is objectively documented or death, whichever occurs first. |
| Secondary | Pooled Cohort 1/1a: Duration of Response (DOR) Between Treatment Groups | Up to 5 years | |
| Secondary | Cohort 1: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA) | Up to 5 years | PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per iwCLL guidelines with modifications for treatment-related lymphocytosis in participants with CLL and the Revised Criteria for Response for Malignant Lymphoma in participants with SLL. |
| Secondary | Pooled Cohort 1/1a: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA) | Up to 5 years | |
| Secondary | Cohort 1: Patient-reported Outcomes as Assessed by the (European Quality Of Life 5D 5L) EQ-5D-5L Questionnaire | Up to 5 years | |
| Secondary | Cohort 1: Patient-reported Outcomes as Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire. | Up to 5 years |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) | Up to approximately 3 years and 7 months (as of cut-off date of 07MAY2021) | ITT analysis set included all enrolled participants who were assigned to a treatment group | Months | MEDIAN |
| SECONDARY | Cohort 1: Overall Response Rate (ORR) Between Treatment Groups as Determined by ICR | Up to 5 years | |||
| SECONDARY | Pooled Cohort 1/1a: Overall Response Rate (ORR) Between Treatment Groups | Up to 5 years | |||
| SECONDARY | Cohort 1: Overall Survival (OS) Between Treatment Groups as Determined by the ICR | Up to 5 years | |||
| SECONDARY | Cohort 1: Duration of Response (DOR) Between Treatment Groups as Determined by the ICR | Up to 5 years | |||
| SECONDARY | Pooled Cohort 1/1a: Duration of Response (DOR) Between Treatment Groups | Up to 5 years | |||
| SECONDARY | Cohort 1: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA) | Up to 5 years | |||
| SECONDARY | Pooled Cohort 1/1a: Progression-free Survival (PFS) Between Treatment Groups Determined by Investigator Assessment (IA) | Up to 5 years | |||
| SECONDARY | Cohort 1: Patient-reported Outcomes as Assessed by the (European Quality Of Life 5D 5L) EQ-5D-5L Questionnaire | Up to 5 years | |||
| SECONDARY | Cohort 1: Patient-reported Outcomes as Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire. | Up to 5 years |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 33.7 | 95% Confidence Interval 28.1 to NA | Months | |
| Cohort 1: Progression-free Survival (PFS) as Determined by Independent Central Review (ICR) | Cohort 1: Zanubrutinib Without Del(17p) | NA | 95% Confidence Interval NA to NA | Months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 238 | |
| Overall Study | STARTED | Cohort 1: Zanubrutinib Without Del(17p) | 241 | |
| Overall Study | STARTED | Cohort 2: Zanubrutinib With Del(17p) | 111 | |
| Overall Study | Treated | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 227 | |
| Overall Study | Treated | Cohort 1: Zanubrutinib Without Del(17p) | 240 | |
| Overall Study | Treated | Cohort 2: Zanubrutinib With Del(17p) | 111 | |
| Overall Study | COMPLETED | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 0 | |
| Overall Study | COMPLETED | Cohort 1: Zanubrutinib Without Del(17p) | 0 | |
| Overall Study | COMPLETED | Cohort 2: Zanubrutinib With Del(17p) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 238 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events951
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 | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 41 | 227 | 65 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1: Zanubrutinib Without Del(17p) | 11 | 240 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: Zanubrutinib With Del(17p) | 5 | 111 | 7 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 7 | 227 | 12 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 1: Zanubrutinib Without Del(17p) | 1 | 240 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Cohort 2: Zanubrutinib With Del(17p) | 0 | 111 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 101 | 227 | 233 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1: Zanubrutinib Without Del(17p) | 30 | 240 | 62 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2: Zanubrutinib With Del(17p) | 13 | 111 | 28 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 30 | 227 | 62 |
1 to 10 of 951Source ClinicalTrials.gov
See all 951 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 14 | 238 |
| Total, all-cause mortality | Cohort 1: Zanubrutinib Without Del(17p) | 16 | 241 |
| Total, all-cause mortality | Cohort 2: Zanubrutinib With Del(17p) | 8 | 111 |
| Total, other adverse events | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 214 | 227 |
| Total, other adverse events | Cohort 1: Zanubrutinib Without Del(17p) | 208 | 240 |
| Total, other adverse events | Cohort 2: Zanubrutinib With Del(17p) | 104 | 111 |
| Total, serious adverse events | Cohort 1: Bendamustine + Rituximab Without Del(17p) | 113 | 227 |
| Total, serious adverse events | Cohort 1: Zanubrutinib Without Del(17p) | 88 | 240 |
| Total, serious adverse events | Cohort 2: Zanubrutinib With Del(17p) | 45 | 111 |
Source ClinicalTrials.gov
Papers10
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 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/NCT03336333
GET https://conductscience.org/api/trials/v1/NCT03336333/registered?page=2