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A phase 3 trial of Acalabrutinib, Rituximab, Idelalisib and Bendamustine in chronic lymphocytic leukaemia, run by Acerta Pharma BV, active and no longer recruiting.
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL is a phase 3 interventional study registered as NCT02970318 by Acerta Pharma BV, with 310 participants enrolled, started 2017-02-02 and due to reach its primary completion in 2021-09-03. Interventions recorded: Acalabrutinib (ACP-196), Rituximab, Idelalisib and Bendamustine. Results have been posted on the registry.
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.
310 enrolled.
Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.; Figures from the ClinicalTrials.gov results section (first posted 2023-06-29), not from a publication · 95% CI 14.0 to 17.1
SourceFigures from the ClinicalTrials.gov results section (first posted 2023-06-29), not from a publication
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free Survival (PFS) Per Independent Review Committee (IRC) Assessmentprimary | Arm A: Acalabrutinib Monotherapy | 155 | Kaplan-Meier Estimated Median PFS and 95% were not reached for Arm A.; Figures from the ClinicalTrials.gov results section (first posted 2023-06-29), not from a publication | 0.31 (0.2 to 0.49) | <0.0001 | link |
| Arm B: Investigators Choice | 155 | 16.5 months | ||||
| IRC-assessed Overall Response Rate (ORR) Per IWCLL 2008 Criteria Based on Data Cutoff 15 January 2019 From Interim Analysis | Arm A: Acalabrutinib Monotherapy | 155 | 126 participants | - | 0.2248 | link |
| Arm B: Investigator's Choice | 155 | 117 participants |
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