ACP-196 (acalabrutinib), a novel Bruton tyrosine kinase (BTK) inhibitor, for treatment of chronic lymphocytic leukemia, Richter’s syndrome or prolymphocytic leukemia

Study identifier:ACE-CL-001

ClinicalTrials.gov identifier:NCT02029443

EudraCT identifier:2014-000440-15

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects with Chronic Lymphocytic Leukemia, Richter’s Syndrome or Prolymphocytic Leukemia

Medical condition

Chronic Lymphocytic Leukemia

Phase

Phase 1/2

Healthy volunteers

No

Study drug

Acalabrutinib

Sex

All

Actual Enrollment

306

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 30 Jan 2014
Primary Completion Date: 15 Jul 2021
Estimated Study Completion Date: 06 Sept 2027

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AcertaPharma

Sponsors

AcertaPharma

Collaborators

-

Inclusion and exclusion criteria