OncRef

Clinical Trial: NCT02029443

ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:Acerta Pharma BV
Information Provided By:Acerta Pharma BV
Last Update Posted:2026-05-05

Study Overview

Brief Summary

This study is evaluating the safety and efficacy of a new BTK inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

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

Conditions

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Richter's Syndrome, Prolymphocytic Leukemia

Intervention / Treatment

  • Drug: Acalabrutinib

Other Study ID Numbers

  • ACE-CL-001
  • 2023-509346-35-00
  • 2014-000440-15
  • 2014
  • 2023

Start Date (Actual)

2014-01-30

Primary Completion Date (Actual)

2021-07-15

Study Completion Date (Estimated)

2027-06-09

Enrollment (Actual)

306

Study Type

Interventional

Phase

Phase 1, Phase 2