Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Active, enrolledPhase 1, PHASE2Results postedLast updated 15 October 2025
What this trial tests
Phase 1, PHASE2 trial testing acalabrutinib in Non Hodgkin Lymphoma in 113 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Non Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 1: Incidence of Treatment-emergent Adverse Events.Primary· 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).
Group
Value
95% CI
Part 1: Acalabrutinib 100 mg BID
12
Part 1: Acalabrutinib 100 mg BID + Rituximab
13
Part 1: Relapsed or Refractory Acalabrutinib 200 mg QD
2
Part 1: Acalabrutinib 100 mg Rituximab
13
Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).Primary· 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).
Group
Value
95% CI
Part 2: Acalabrutinib
60.5
44.4 – 75.0
Part 2: Acalabrutinib + Rituximab
0
0 – 97.5
Part 3: Incidence of Treatment-emergent Adverse Events.Primary· 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).
Group
Value
95% CI
Part 3: Acalabrutinib + Rituximab + Lenalidomide 15 mg
Time frame: Treatment-emergent period, i.e. from the first dose of study drug until study discontinuation, 30 days after the last dose of study drug, or one day before the initiation of the subsequent anticancer therapy, whichever occurred earlier, up to 80.7 months for part 1, up to 65.1 months for part 2, and up to 54.3 months for part 3..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL.
Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR.
Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06205498 — Acalabrutinib Real World Italian obSErvational Study -ARISE
· active not recruiting
NCT04529772 — A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
· Phase 3
· active not recruiting
NCT03968848 — Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
· Phase 1
· completed
NCT03492125 — A Study Of The Selective PKC-β Inhibitor MS- 553
· Phase 1, PHASE2
· terminated
NCT03205046 — A Study of Acalabrutinib and Vistusertib in Subjects With Relapsed/Refractory B-cell Malignancies
· Phase 1, PHASE2
· terminated
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NCT04529772 — A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
· Phase 3
· active not recruiting
NCT04497948 — Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19
· Phase 1
· terminated
NCT05140096 — A Study to Evaluate the Effect of Pharmacokinetics (PK) of Acalabrutinib and Its Active Metabolite (ACP-5862) When Admin
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· completed
NCT03836261 — Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus
· Phase 3
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NCT03968848 — Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Acerta Pharma BV
Last refreshed: 15 October 2025
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