Study identifier:ACE-CL-309
ClinicalTrials.gov identifier:NCT02970318
EudraCT identifier:2015-004454-17
CTIS identifier:N/A
A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with R/R Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Phase 3
No
Acalabrutinib (ACP-196), Rituximab, Idelalisib, Bendamustine
All
310
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Verified 01 Nov 2024 by AcertaPharma
AcertaPharma
-
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).
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Acalabrutinib (ACP-196) Acalabrutinib (ACP-196) Monotherapy | Drug: Acalabrutinib (ACP-196) Acalabrutinib monotherapy |
Active Comparator: Rituximab Plus Idelalisib or Bendamustine Investigator’s Choice of Rituximab Plus Idelalisib or Bendamustine | Drug: Rituximab Rituximab in combination with idelalisib or bendamustine Drug: Idelalisib Idelalisib in combination with rituximab Drug: Bendamustine Bendamustine in combination with rituximab |