A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509347-27-00

Acronym

ACE-CL-006

Enrollment

Registered

2024-05-14

Start date

2015-09-30

Completion date

Unknown

Last updated

2025-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk Chronic Lymphocytic Leukaemia

Brief summary

To assess whether ACP-196 is non-inferior to ibrutinib with respect to progression-free survival (PFS) based on independent review committee (IRC) assessment in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) with high-risk prognostic markers.

Detailed description

To compare between ACP-196 and ibrutinib in terms of: •Incidence of Grade ≥ 3 infections •Incidence of Richter's transformation •Incidence of atrial fibrillation •OS

Interventions

DRUGIMBRUVICA 140 mg hard capsules

DRUGCalquence 100 mg film-coated tablets

DRUGCalquence 100 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To assess whether ACP-196 is non-inferior to ibrutinib with respect to progression-free survival (PFS) based on independent review committee (IRC) assessment in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) with high-risk prognostic markers.	—

Secondary

Measure	Time frame
To compare between ACP-196 and ibrutinib in terms of: •Incidence of Grade ≥ 3 infections •Incidence of Richter's transformation •Incidence of atrial fibrillation •OS	—

Countries

Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026