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A phase 1/2 trial of Acalabrutinib in mantle cell lymphoma, run by AstraZeneca, active and no longer recruiting.
Study of Acalabrutinib in Chinese Adult Subjects With Relapsed or Refractory Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia or Other B-cell Malignancies is a phase 1/2 interventional study registered as NCT03932331 by AstraZeneca, with 105 participants enrolled, started 2020-04-29 and due to reach its primary completion in 2022-12-22. Interventions recorded: Acalabrutinib. Conditions listed: Phase I: Relapsed or Refractory B-cell Malignancies, Phase II Cohort A: Relapsed or Refractory Mantle Cell Lymphoma, Phase II Cohort B: Relapsed or Refractory Chronic Lymphocytic Leukemia. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
105 enrolled.
95% CI 65.5 to 93.2; Figures from the ClinicalTrials.gov results section (first posted 2025-03-20), not from a publication · 95% CI 75.4 to 94.1
SourceThe OS is not mature to report median and 95% confidence interval at time of analysis.; Figures from the ClinicalTrials.gov results section (first posted 2025-03-20), not from a publication · 95% CI 87.3 to 99.2
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Phase II: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR)primary | Phase II MCL | 34 | 82.4% | - | - | link |
| Phase II CLL | 60 | 86.7% | ||||
| Phase II: Percentage of Participants With Overall Survival (OS) at Month 6 | Phase II MCL | 34 | The OS is not mature to report median and 95% confidence interval at time of analysis.; Figures from the ClinicalTrials.gov results section (first posted 2025-03-20), not from a publication | - | - | link |
| Phase II CLL | 60 | 96.7% |
Shares Acalabrutinib, Mantle cell lymphoma, AstraZeneca, Small-molecule kinase inhibitors.
Shares Acalabrutinib, Mantle cell lymphoma, AstraZeneca, Small-molecule kinase inhibitors.
Shares Acalabrutinib, AstraZeneca, Small-molecule kinase inhibitors.
Shares Acalabrutinib, AstraZeneca, Small-molecule kinase inhibitors.
Shares Acalabrutinib, Mantle cell lymphoma, AstraZeneca, Small-molecule kinase inhibitors.
Shares Acalabrutinib, AstraZeneca, Small-molecule kinase inhibitors.
Shares Acalabrutinib, AstraZeneca, Small-molecule kinase inhibitors.
Shares Acalabrutinib, AstraZeneca, Small-molecule kinase inhibitors.