A phase III, multi-center, open-label, randomized study of oral asciminib versus Investigator selected TKI in patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508838-33-00

Acronym

CABL001J12301

Enrollment

159

Registered

2024-05-13

Start date

2021-10-06

Completion date

Unknown

Last updated

2026-01-22

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

Conditions

Chronic Myeloid Leukemia

Brief summary

Major Molecular Response (MMR) at Week 48 (Yes/No)

Detailed description

Major Molecular Response (MMR) at Week 96 (Yes/No), Major Molecular response (MMR) at Week 96 (Yes/No)

Interventions

DRUGIMATINIB

DRUGDASATINIB

DRUGNILOTINIB

DRUGBOSUTINIB

DRUGASCIMINIB HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Major Molecular Response (MMR) at Week 48 (Yes/No)	—

Secondary

Measure	Time frame
Major Molecular Response (MMR) at Week 96 (Yes/No), Major Molecular response (MMR) at Week 96 (Yes/No)	—

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Norway, Portugal, Slovakia, Spain, Sweden

Outcome results

None listed

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