Clinical Trial

Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.

Study acronym: ASC4TARGET
Recruiting Phase 2
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Summary
The objective of this Phase II study is to assess the potential of asciminib in managing CML-CP or CML-AP in patient carrying the T315I mutation. The presence of this mutation introduces treatment difficulties due to the limited available options. The study seeks to collect additional data on the effectiveness and safety of asciminib for these patients. By determining the drug's capacity to manage the disease and enhance patients outcomes, the study is designed to fill the unmet medical need and potentially offer a new therapeutic path for patients at a treatment deadlock.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-17; most recent amendment 2026-04-17.
Status change: Not Yet Recruiting → Recruiting 2025-03-03
Trial Details
NCT Number NCT06514534
Lead Sponsor Novartis Pharmaceuticals
Conditions Chronic Myeloid Leukemia (CML)
Enrollment 20 participants
Start Date 2025-02-18
Primary Completion 2029-02-17 (estimated)
Study Completion 2029-02-18 (estimated)
Updated on ClinicalTrials.gov 2026-04-21