Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients - ASSURE

Study identifier:D8220C00008

ClinicalTrials.gov identifier:NCT04008706

EudraCT identifier:2019-001573-89

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 3b, Multicenter, Open-Label, Single-Arm Study of Acalabrutinib (ACP-196) in Subjects with Chronic Lymphocytic Leukemia.

Medical condition

Chronic Lymphocytic Leukemia

Phase

Phase 3

Healthy volunteers

No

Study drug

Acalabrutinib

Sex

All

Actual Enrollment

552

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 17 Sept 2019
Estimated Primary Completion Date: 01 Sept 2025
Estimated Study Completion Date: 01 Sept 2025

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria