Trials / Active Not Recruiting
Active Not RecruitingNCT02970318
A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 310 (actual)
- Sponsor
- Acerta Pharma BV · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acalabrutinib (ACP-196) | Acalabrutinib monotherapy |
| DRUG | Rituximab | Rituximab in combination with idelalisib or bendamustine |
| DRUG | Idelalisib | Idelalisib in combination with rituximab |
| DRUG | Bendamustine | Bendamustine in combination with rituximab |
Timeline
- Start date
- 2017-02-02
- Primary completion
- 2021-09-03
- Completion
- 2027-10-01
- First posted
- 2016-11-22
- Last updated
- 2026-02-06
- Results posted
- 2023-06-29
Locations
157 sites across 25 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, France, Germany, Hong Kong, Hungary, Israel, Italy, New Zealand, Poland, Russia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02970318. Inclusion in this directory is not an endorsement.