Study identifier:ACE-CL-006
ClinicalTrials.gov identifier:NCT02477696
EudraCT identifier:2014-005530-64
CTIS identifier:2023-509347-27-00
A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Phase 3
No
Acalabrutinib, Ibrutinib
All
533
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verified 01 Jun 2025 by AcertaPharma
AcertaPharma
-
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
Location
Location
New Hyde Park, NY, United States, 11042
Location
Istanbul, Turkey, 34452
Location
Creteil, France, 94010
Location
Harvey, IL, United States, 60426
Location
Lodz, Poland, 93-510
Location
Amsterdam, Netherlands, 1105 AZ
Location
Murcia, Spain, 30008
Location
Tampa, FL, United States, 33612
Arms | Assigned Interventions |
---|---|
Experimental: Acalabrutinib Participants will receive oral acalabrutinib 100 mg twice daily (BID) until disease progression (PD), or unacceptable toxicity, or other reasons for discontinuation, whichever occurs first. | Drug: Acalabrutinib Participants will receive oral acalabrutinib as stated in arm description. Other Name: ACP-196 |
Active Comparator: Ibrutinib Participants will receive oral ibrutinib 420 mg once daily (QD) until PD, or unacceptable toxicity, or other reasons for discontinuation, whichever occurrs first. | Drug: Ibrutinib Participants will receive oral ibrutinib as stated in arm description. |
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