A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
Summary
This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).
Timeline
- Start
- 2017-02-02
- Primary completion
- 2021-09-03
- Completion
- 2027-10-01
Outcome
Met primary endpoint
registry Arm A: Acalabrutinib Monotherapy vs Arm B: Investigators Choice; p <0.0001; Hazard Ratio (HR) 0.31 (95% CI 0.20 to 0.49) NCT02970318 ↗
paper median PFS was significantly longer with acalabrutinib monotherapy (PFS not reached) compared with investigator's choice (16.5 months [95% CI, 14.0 to 17.1 months]; hazard ratio, 0.31 [95% CI, 0.20 to 0.49]; P < .0001). PMID 32459600 ↗
release “the Phase III ASCEND (ACE-CL-309) trial in relapsed or refractory CLL, which recently met its primary endpoint” astrazeneca.com ↗
release “The trial previously met the primary endpoint of Independent Review Committee-assessed progression-free survival at the interim analysis.” astrazeneca.com ↗
release “ASCEND Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) maintained a statistically significant progression-free survival (PFS) benefit at three years” astrazeneca.com ↗
Publications
- Eek D, Ivanescu C, Corredoira L, Meyers O, Cella D. Content validity and psychometric evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue scale in patients with chronic lymphocytic leukemia. J Patient Rep Outcomes. 2021 Mar 11;5(1):27. doi: 10.1186/s41687-021-00294-1.
- Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, Kaplan P, Kraychok I, Illes A, de la Serna J, Dolan S, Campbell P, Musuraca G, Jacob A, Avery E, Lee JH, Liang W, Patel P, Quah C, Jurczak W. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Sep 1;38(25):2849-2861. doi: 10.1200/JCO.19.03355. Epub 2020 May 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | — | — |
| Comparator | Bendamustine | Small molecule | — | — |
| Comparator | Idelalisib | Small molecule | — | — |
| Comparator | Rituximab | Monoclonal antibody | — | — |