Trial · NCT02475681
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
NCT02475681, Phase 3, Active not recruiting, Acerta Pharma BV; results first posted 2023-01-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL. Trials, record NCT02475681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02475681
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
- NCT number
- NCT02475681
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 535 participants, actual
- Lead sponsor
- Acerta Pharma BV
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Acalabrutinib, Obinutuzumab, Chlorambucil
- First posted
- 2015-06-19
- Last updated
- 2026-08-25
- Other registries' IDs
- eudract:2014-005582-73
- Results first posted
- 2023-01-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B | IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months. | To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib in combination with obinutuzumab (Arm B) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, defined as the time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause, whichever comes first. |
| Secondary | Progression-free Survival by IRC Assessment Arm A Versus Arm C | IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months. | To evaluate the efficacy of obinutuzumab in combination with chlorambucil (Arm A) compared with acalabrutinib monotherapy (Arm C) based on IRC assessment of progression-free survival (PFS) per International Workshop on Chronic Lymphocytic Leukemia criteria (IWCLL; Hallek et al. 2008) with incorporation of the clarification for treatment-related lymphocytosis (Cheson et al. 2012), hereafter referred to as IWCLL 2008 criteria, in subjects with previously untreated CLL. PFS, defined as the time from date of randomization to the date of first IRC-assessed disease progression or death due to any cause, whichever comes first. |
| Secondary | IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C | IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months. | ORR was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, or PR at or before initiation of subsequent anticancer therapy. ORR including PRL was defined as the proportion of subjects who achieved a best response of CR, CRi, nPR, PR or PRL at or before initiation of subsequent anticancer therapy |
| Secondary | Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C | From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first assessed up to 40 months of follow-up. | TTNT was defined as the time from randomization to start date of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first. TTNT was analyzed in the same fashion as that for the primary efficacy analysis |
| Secondary | Overall Survival (OS) in Arm A Versus Arm B and Arm A Versus Arm C | From randomization date until death, withdrawal by subject, lost to follow-up, or by analysis data cut off date on 08Feb2019 whichever comes first up to 40 months of follow-up. | OS was defined as the time from the date of randomization to death due to any cause. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B | IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months. | Intent to Treat (ITT) | Months | MEDIAN |
| SECONDARY | Progression-free Survival by IRC Assessment Arm A Versus Arm C | IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months. | Intent to Treat (ITT) | Months | MEDIAN |
| SECONDARY | IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C | IRC assessments were done from randomization date until disease progression or death or IRC discontinuation date on 08Feb2019 (as the IA based on this data cutoff date showed the study crossing superiority boundary) whichever comes first up to 40 months. | Intent to Treat | percentage of participants | NUMBER |
| SECONDARY | Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C | From randomization date to start of non-protocol specified subsequent anticancer therapy for CLL or death due to any cause, whichever came first assessed up to 40 months of follow-up. | Intent to Treat (ITT) | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Arm A Versus Arm B and Arm A Versus Arm C | From randomization date until death, withdrawal by subject, lost to follow-up, or by analysis data cut off date on 08Feb2019 whichever comes first up to 40 months of follow-up. | Intent to Treat (ITT) | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B | Arm A: Obinutuzumab in Combination With Chlorambucil | 22.6 | 95% Confidence Interval 20.2 to 27.8 | Months | |
| Progression-free Survival by IRC (Independent Review Committee) Assessment in Arm A Compared to Arm B | Arm B: Acalabrutinib in Combination With Obinutuzumab | NA | 95% Confidence Interval NA to NA | Months | |
| Progression-free Survival by IRC Assessment Arm A Versus Arm C | Arm A: Obinutuzumab in Combination With Chlorambucil | 22.6 | 95% Confidence Interval 20.2 to 27.6 | Months | |
| Progression-free Survival by IRC Assessment Arm A Versus Arm C | Arm C: Acalabrutinib Monotherapy | NA | 95% Confidence Interval 34.2 to NA | Months | |
| IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C | Arm A: Obinutuzumab in Combination With Chlorambucil | 78.5 | 95% Confidence Interval 71.9 to 83.9 | percentage of participants | |
| IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C | Arm B: Acalabrutinib in Combination With Obinutuzumab | 93.9 | 95% Confidence Interval 89.3 to 96.5 | percentage of participants | |
| IRC-assessed Objective Response Rate (ORR) in Arm A Versus Arm B and Arm A Versus Arm C | Arm C: Acalabrutinib Monotherapy | 85.5 | 95% Confidence Interval 79.6 to 89.9 | percentage of participants | |
| Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C | Arm A: Obinutuzumab in Combination With Chlorambucil | NA | 95% Confidence Interval 28.9 to NA | Months | |
| Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C | Arm B: Acalabrutinib in Combination With Obinutuzumab | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Next Treatment (TTNT) in Arm A Versus Arm B and Arm A Versus Arm C | Arm C: Acalabrutinib Monotherapy | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Obinutuzumab in Combination With Chlorambucil | 177 | |
| Overall Study | STARTED | Arm B: Acalabrutinib in Combination With Obinutuzumab | 179 | |
| Overall Study | STARTED | Arm C: Acalabrutinib Monotherapy | 179 | |
| Overall Study | Crossed Over From Arm A to Arm C | Arm A: Obinutuzumab in Combination With Chlorambucil | 45 | |
| Overall Study | Crossed Over From Arm A to Arm C | Arm B: Acalabrutinib in Combination With Obinutuzumab | 0 | |
| Overall Study | Crossed Over From Arm A to Arm C | Arm C: Acalabrutinib Monotherapy | 0 | |
| Overall Study | COMPLETED | Arm A: Obinutuzumab in Combination With Chlorambucil | 145 | |
| Overall Study | COMPLETED | Arm B: Acalabrutinib in Combination With Obinutuzumab | 0 | |
| Overall Study | COMPLETED | Arm C: Acalabrutinib Monotherapy | 0 | |
| Overall Study | NOT COMPLETED | Arm A: Obinutuzumab in Combination With Chlorambucil | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events912
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 | Neutropenia | Blood and lymphatic system disorders | Arm A: Obinutuzumab in Combination With Chlorambucil | 76 | 169 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm B: Acalabrutinib in Combination With Obinutuzumab | 56 | 178 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm C: Acalabrutinib Monotherapy | 19 | 179 | |
| other | Neutropenia | Blood and lymphatic system disorders | Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy | 1 | 45 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A: Obinutuzumab in Combination With Chlorambucil | 24 | 169 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm B: Acalabrutinib in Combination With Obinutuzumab | 23 | 178 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm C: Acalabrutinib Monotherapy | 13 | 179 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy | 3 | 45 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A: Obinutuzumab in Combination With Chlorambucil | 20 | 169 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Acalabrutinib in Combination With Obinutuzumab | 21 | 178 |
1 to 10 of 912Source ClinicalTrials.gov
See all 912 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Obinutuzumab in Combination With Chlorambucil | 17 | 177 |
| Total, all-cause mortality | Arm B: Acalabrutinib in Combination With Obinutuzumab | 9 | 179 |
| Total, all-cause mortality | Arm C: Acalabrutinib Monotherapy | 11 | 179 |
| Total, all-cause mortality | Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy | 2 | 45 |
| Total, other adverse events | Arm A: Obinutuzumab in Combination With Chlorambucil | 167 | 169 |
| Total, other adverse events | Arm B: Acalabrutinib in Combination With Obinutuzumab | 171 | 178 |
| Total, other adverse events | Arm C: Acalabrutinib Monotherapy | 170 | 179 |
| Total, other adverse events | Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy | 37 | 45 |
| Total, serious adverse events | Arm A: Obinutuzumab in Combination With Chlorambucil | 37 | 169 |
| Total, serious adverse events | Arm B: Acalabrutinib in Combination With Obinutuzumab | 69 | 178 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
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/NCT02475681
GET https://conductscience.org/api/trials/v1/NCT02475681/events?page=2