Trial · NCT02477696
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
NCT02477696, Phase 3, Active not recruiting, Acerta Pharma BV; results first posted 2022-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL). Trials, record NCT02477696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02477696
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
- NCT number
- NCT02477696
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 533 participants, actual
- Lead sponsor
- Acerta Pharma BV
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Acalabrutinib, Ibrutinib
- First posted
- 2015-06-23
- Last updated
- 2026-08-26
- Other registries' IDs
- eudract:2014-005530-64
- Results first posted
- 2022-01-28
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment | Baseline (Days -28 to -1) through 55.2 months (maximum observed duration) | The PFS is defined as the time from date of randomization to the date of first IRC-assessed PD or death due to any cause, whichever occurred first. PD (per International Workshop on Chronic Lymphocytic Leukemia \[iwCLL\] 2008 criteria): Lymphocytes \>= 50% increase over baseline, or \>= 50% increase in lymphadenopathy/hepatomegaly/splenomegaly, or \>= 50% platelets or \> 2 g/dL hemoglobin decreases from baseline secondary to chronic lymphocytic leukemia (CLL). The PFS is assessed using the Kaplan-Meier method. |
| Secondary | Number of Participants With Treatment-emergent Infections Grade >= 3 | Day 1 through 83.5 months (maximum observed duration) | Number of participants with treatment-emergent infections Grade \>=3 are reported. |
| Secondary | Number of Participants With Treatment-emergent Richter's Transformation | Day 1 through 83.5 months (maximum observed duration) | Richter's transformation is defined as the occurrence of an aggressive lymphoma in participants with a previous or concomitant diagnosis of CLL. Richter's transformation was assessed by central pathology. Number of participants with treatment-emergent Richter's transformation are reported. |
| Secondary | Number of Participants With Treatment-emergent Atrial Fibrillation | Day 1 through 83.5 months (maximum observed duration) | Number of participants with treatment-emergent atrial fibrillation (including atrial flutter) are reported. |
| Secondary | Overall Survival (OS) | Baseline (Days -28 to -1) through 83.7 months (maximum observed duration) | The OS is defined as the time from date of randomization to date of death due to any cause. The OS is assessed using the Kaplan-Meier method. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Day 1 through 83.5 months (maximum observed duration) | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. |
| Secondary | Number of Participants With Treatment-emergent Laboratory Abnormalities | Day 1 through 83.5 months (maximum observed duration) | Number of participants with treatment-emergent laboratory abnormalities are reported. Laboratory abnormality is defined as any abnormal finding during analysis of hematology and serum chemistry. |
| Secondary | Number of Participants With Abnormal Vital Signs Reported as TEAEs | Day 1 through 83.5 months (maximum observed duration) | Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body temperature, blood pressure, heart rate, and respiratory rate). |
| Secondary | Percentage of Participants With Lymphocytosis | Day 1 through 83.5 months (maximum observed duration) | Percentage of participants with at least one occurrence of treatment-related lymphocytosis defined as an elevation in ALC of \>= 50% compared with baseline and a postbaseline assessment of \> 5000/μL in the peripheral blood are reported. |
| Secondary | Number of Participants With Electrocardiogram (ECG) Abnormality at Baseline | Baseline (Days -28 to -1) | Number of participants with ECG abnormality at baseline are reported. |
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 | Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment | Baseline (Days -28 to -1) through 55.2 months (maximum observed duration) | ITT population included all participants randomized and were analyzed according to the arm to which they were randomly assigned. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Infections Grade >= 3 | Day 1 through 83.5 months (maximum observed duration) | Safety population included all participants who received at least one dose of study drug and were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Richter's Transformation | Day 1 through 83.5 months (maximum observed duration) | Safety population included all participants who received at least one dose of study drug and were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Atrial Fibrillation | Day 1 through 83.5 months (maximum observed duration) | Safety population included all participants who received at least one dose of study drug and were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival (OS) | Baseline (Days -28 to -1) through 83.7 months (maximum observed duration) | ITT population included all participants randomized and were analyzed according to the arm to which they were randomly assigned. | Months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | Day 1 through 83.5 months (maximum observed duration) | Safety population included all participants who received at least one dose of study drug and were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Laboratory Abnormalities | Day 1 through 83.5 months (maximum observed duration) | Safety population included all participants who received at least one dose of study drug and were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Vital Signs Reported as TEAEs | Day 1 through 83.5 months (maximum observed duration) | Safety population included all participants who received at least one dose of study drug and were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Lymphocytosis | Day 1 through 83.5 months (maximum observed duration) | Safety population included all participants who received at least one dose of study drug and were analyzed as treated. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Electrocardiogram (ECG) Abnormality at Baseline | Baseline (Days -28 to -1) | Safety population included all participants who received at least one dose of study drug and were analyzed as treated. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group126
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment | Acalabrutinib | 38.4 | 95% Confidence Interval 33.0 to 38.6 | Months | |
| Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment | Ibrutinib | 38.4 | 95% Confidence Interval 33.0 to 41.6 | Months | |
| Number of Participants With Treatment-emergent Infections Grade >= 3 | Acalabrutinib | 98 | Participants | ||
| Number of Participants With Treatment-emergent Infections Grade >= 3 | Ibrutinib | 101 | Participants | ||
| Number of Participants With Treatment-emergent Richter's Transformation | Acalabrutinib | 13 | Participants | ||
| Number of Participants With Treatment-emergent Richter's Transformation | Ibrutinib | 14 | Participants | ||
| Number of Participants With Treatment-emergent Atrial Fibrillation | Acalabrutinib | 32 | Participants | ||
| Number of Participants With Treatment-emergent Atrial Fibrillation | Ibrutinib | 49 | Participants | ||
| Overall Survival (OS) | Acalabrutinib | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Ibrutinib | NA | 95% Confidence Interval 65.0 to NA | Months |
1 to 10 of 126Source ClinicalTrials.gov
See all 126 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acalabrutinib | 268 | |
| Overall Study | STARTED | Ibrutinib | 265 | |
| Overall Study | Treated | Acalabrutinib | 265 | |
| Overall Study | Treated | Ibrutinib | 264 | |
| Overall Study | COMPLETED | Acalabrutinib | 0 | |
| Overall Study | COMPLETED | Ibrutinib | 0 | |
| Overall Study | NOT COMPLETED | Acalabrutinib | 268 | |
| Overall Study | NOT COMPLETED | Ibrutinib | 265 |
Source ClinicalTrials.gov
Adverse events846
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 | Hypogammaglobulinaemia | Immune system disorders | Acalabrutinib | 13 | 266 | 16 |
| other | Hypogammaglobulinaemia | Immune system disorders | Ibrutinib | 15 | 263 | 17 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Acalabrutinib | 38 | 266 | 70 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ibrutinib | 36 | 263 | 60 |
| other | Bronchitis | Infections and infestations | Acalabrutinib | 35 | 266 | 58 |
| other | Bronchitis | Infections and infestations | Ibrutinib | 23 | 263 | 28 |
| other | COVID-19 | Infections and infestations | Acalabrutinib | 29 | 266 | 34 |
| other | COVID-19 | Infections and infestations | Ibrutinib | 24 | 263 | 28 |
| other | Conjunctivitis | Infections and infestations | Acalabrutinib | 12 | 266 | 13 |
| other | Conjunctivitis | Infections and infestations | Ibrutinib | 15 | 263 | 19 |
1 to 10 of 846Source ClinicalTrials.gov
See all 846 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acalabrutinib | 89 | 266 |
| Total, all-cause mortality | Ibrutinib | 106 | 263 |
| Total, other adverse events | Acalabrutinib | 251 | 266 |
| Total, other adverse events | Ibrutinib | 251 | 263 |
| Total, serious adverse events | Acalabrutinib | 161 | 266 |
| Total, serious adverse events | Ibrutinib | 177 | 263 |
Source ClinicalTrials.gov
Papers6
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Acalabrutinib vs Ibrutinib: Number of Participants With Treatment-emergent Richter's Transformation | Trial comparisons |
| Acalabrutinib vs Ibrutinib: Number of Participants With Treatment-emergent Atrial Fibrillation | Trial comparisons |
| Acalabrutinib vs Ibrutinib: Number of Participants With Treatment-emergent Infections Grade >= 3 | Trial comparisons |
| Acalabrutinib vs Ibrutinib: deaths from any cause | Trial comparisons |
| Acalabrutinib 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.
The record and each of its lists are JSON, twenty rows a page. No key.
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