Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
Summary
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
Timeline
- Start
- 2015-07-28
- Primary completion
- 2020-09-15
- Completion
- 2028-01-03
Outcome
Met primary endpoint
paper After a median follow-up of 40.9 months, acalabrutinib was determined to be noninferior to ibrutinib with a median PFS of 38.4 months in both arms PMID 34310172 ↗
release “Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS)” astrazeneca.com ↗
release “At a median follow up of 40.9 months, the ELEVATE-RR trial met its primary endpoint of PFS non-inferiority versus ibrutinib” astrazeneca.com ↗
Publications
- Byrd JC, Hakre S, Ghia P. How well does acalabrutinib work and how safe is it to treat patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have had previous treatments? a plain language summary of 2 key studies. Future Oncol. 2025 Nov;21(26):3343-3357. doi: 10.1080/14796694.2025.2494976. Epub 2025 Jun 8.
- Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024.
- Woyach JA, Jones D, Jurczak W, Robak T, Illes A, Kater AP, Ghia P, Byrd JC, Seymour JF, Long S, Mohamed N, Benrashid S, Lai TH, De Jesus G, Lai R, de Bruin G, Rule S, Munugalavadla V. Mutational profile in previously treated patients with chronic lymphocytic leukemia progression on acalabrutinib or ibrutinib. Blood. 2024 Sep 5;144(10):1061-1068. doi: 10.1182/blood.2023023659.
- Seymour JF, Byrd JC, Ghia P, Kater AP, Chanan-Khan A, Furman RR, O'Brien S, Brown JR, Munir T, Mato A, Stilgenbauer S, Bajwa N, Miranda P, Higgins K, John E, de Borja M, Jurczak W, Woyach JA. Detailed safety profile of acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia in the ELEVATE-RR trial. Blood. 2023 Aug 24;142(8):687-699. doi: 10.1182/blood.2022018818.
- Kipps TJ. Mining the Microenvironment for Therapeutic Targets in Chronic Lymphocytic Leukemia. Cancer J. 2021 Jul-Aug 01;27(4):306-313. doi: 10.1097/PPO.0000000000000536.
- Byrd JC, Hillmen P, Ghia P, Kater AP, Chanan-Khan A, Furman RR, O'Brien S, Yenerel MN, Illes A, Kay N, Garcia-Marco JA, Mato A, Pinilla-Ibarz J, Seymour JF, Lepretre S, Stilgenbauer S, Robak T, Rothbaum W, Izumi R, Hamdy A, Patel P, Higgins K, Sohoni S, Jurczak W. Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial. J Clin Oncol. 2021 Nov 1;39(31):3441-3452. doi: 10.1200/JCO.21.01210. Epub 2021 Jul 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acalabrutinib | Small molecule | 100 mg | Oral |
| Comparator | Ibrutinib | Small molecule | 420 mg | Oral |