Trial · NCT02180711
Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
NCT02180711, Phase 1, Phase 2, Active not recruiting, Acerta Pharma BV; results first posted 2025-10-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma. Trials, record NCT02180711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02180711
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
- NCT number
- NCT02180711
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 113 participants, actual
- Lead sponsor
- Acerta Pharma BV
- Conditions
- Non Hodgkin Lymphoma
- Interventions
- acalabrutinib, rituximab (IV), Lenalidomide
- First posted
- 2014-07-03
- Last updated
- 2026-09-28
- Other registries' IDs
- eudract:2019-000111-84
- Results first posted
- 2025-10-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Incidence of Treatment-emergent Adverse Events. | From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study). | Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL). |
| Primary | Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL). | Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study). | The objective response rate (ORR) is used to characterize the activity of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL). |
| Primary | Part 3: Incidence of Treatment-emergent Adverse Events. | From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study). | Treatment-emergent adverse events were used to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in participants with relapsed/refractory follicular lymphoma (R/R FL). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Incidence of Treatment-emergent Adverse Events. | From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study). | Number of participants | NUMBER | |
| PRIMARY | Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL). | Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study). | Percentage of participants | NUMBER | |
| PRIMARY | Part 3: Incidence of Treatment-emergent Adverse Events. | From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study). | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Incidence of Treatment-emergent Adverse Events. | Part 1: Acalabrutinib 100 mg BID | 12 | Number of participants | ||
| Part 1: Incidence of Treatment-emergent Adverse Events. | Part 1: Acalabrutinib 100 mg BID + Rituximab | 13 | Number of participants | ||
| Part 1: Incidence of Treatment-emergent Adverse Events. | Part 1: Relapsed or Refractory Acalabrutinib 200 mg QD | 2 | Number of participants | ||
| Part 1: Incidence of Treatment-emergent Adverse Events. | Part 1: Acalabrutinib 100 mg Rituximab | 13 | Number of participants | ||
| Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL). | Part 2: Acalabrutinib | 60.5 | 95% Confidence Interval 44.4 to 75.0 | Percentage of participants | |
| Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL). | Part 2: Acalabrutinib + Rituximab | 0 | 95% Confidence Interval 0 to 97.5 | Percentage of participants | |
| Part 3: Incidence of Treatment-emergent Adverse Events. | Part 3: Acalabrutinib + Rituximab + Lenalidomide 15 mg | 8 | Number of participants | ||
| Part 3: Incidence of Treatment-emergent Adverse Events. | Part3: Acalabrutinib + Rituximab + Lenalidomide+20mg | 21 | Number of participants |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | P1: RR Acalabrutinib 100 mg BID | 12 | |
| Overall Study | STARTED | P1: RR Acalabrutinib 100 mg BID + Rituximab | 13 | |
| Overall Study | STARTED | P1: RR Acalabrutinib 200 mg QD | 2 | |
| Overall Study | STARTED | P1: TN Acalabrutinib 100 mg BID + Rituximab | 13 | |
| Overall Study | STARTED | P2: Acalabrutinib | 43 | |
| Overall Study | STARTED | P2: Acalabrutinib + Rituximab | 1 | |
| Overall Study | STARTED | P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg | 8 | |
| Overall Study | STARTED | P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg | 21 | |
| Overall Study | COMPLETED | P1: RR Acalabrutinib 100 mg BID | 0 | |
| Overall Study | COMPLETED | P1: RR Acalabrutinib 100 mg BID + Rituximab | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events2,336
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 | Nasopharyngitis | Infections and infestations | P1: RR Acalabrutinib 100 mg BID | 0 | 12 | 0 |
| other | Nasopharyngitis | Infections and infestations | P1: RR Acalabrutinib 100 mg BID + Rituximab | 0 | 13 | 0 |
| other | Nasopharyngitis | Infections and infestations | P1: RR Acalabrutinib 200 mg QD | 0 | 2 | 0 |
| other | Nasopharyngitis | Infections and infestations | P1: TN Acalabrutinib 100 mg BID + Rituximab | 1 | 13 | 1 |
| other | Nasopharyngitis | Infections and infestations | P2: Acalabrutinib | 1 | 43 | 1 |
| other | Nasopharyngitis | Infections and infestations | P2: Acalabrutinib + Rituximab | 0 | 1 | 0 |
| other | Nasopharyngitis | Infections and infestations | P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg | 0 | 8 | 0 |
| other | Nasopharyngitis | Infections and infestations | P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg | 0 | 21 | 0 |
| other | Oesophageal candidiasis | Infections and infestations | P1: RR Acalabrutinib 100 mg BID | 0 | 12 | 0 |
| other | Oesophageal candidiasis | Infections and infestations | P1: RR Acalabrutinib 100 mg BID + Rituximab | 0 | 13 | 0 |
1 to 10 of 2,336Source ClinicalTrials.gov
See all 2,336 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | P1: RR Acalabrutinib 100 mg BID | 0 | 12 |
| Total, all-cause mortality | P1: RR Acalabrutinib 100 mg BID + Rituximab | 1 | 13 |
| Total, all-cause mortality | P1: RR Acalabrutinib 200 mg QD | 0 | 2 |
| Total, all-cause mortality | P1: TN Acalabrutinib 100 mg BID + Rituximab | 0 | 13 |
| Total, all-cause mortality | P2: Acalabrutinib | 7 | 43 |
| Total, all-cause mortality | P2: Acalabrutinib + Rituximab | 0 | 1 |
| Total, all-cause mortality | P3: Acalabrutinib + Rituximab + Lenalidomide 15 mg | 1 | 8 |
| Total, all-cause mortality | P3: Acalabrutinib + Rituximab + Lenalidomide 20 mg | 3 | 21 |
| Total, other adverse events | P1: RR Acalabrutinib 100 mg BID | 12 | 12 |
| Total, other adverse events | P1: RR Acalabrutinib 100 mg BID + Rituximab | 13 | 13 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02180711
GET https://conductscience.org/api/trials/v1/NCT02180711/flow?page=2