A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL

Study identifier:ACE-CL-309

ClinicalTrials.gov identifier:NCT02970318

EudraCT identifier:2015-004454-17

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

Chronic Lymphocytic Leukemia

Phase

Phase 3

Healthy volunteers

No

Study drug

Acalabrutinib (ACP-196), Rituximab, Idelalisib, Bendamustine

Sex

All

Actual Enrollment

310

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 02 Feb 2017
Primary Completion Date: 03 Sept 2021
Estimated Study Completion Date: 01 Oct 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2024 by AcertaPharma

Sponsors

AcertaPharma

Collaborators

-

Inclusion and exclusion criteria