OncoMatch/Clinical Trials/NCT06514534
Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib.
Is NCT06514534 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies ABL001/Asciminib for chronic myeloid leukemia (cml).
Treatment: ABL001/Asciminib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Myeloid Leukemia
Biomarker criteria
Required: ABL1 T315I
history of documented T315I mutation after at least one TKI
Required: BCR fusion
Evidence of typical BCR::ABL1 transcript or atypical transcripts at the time of Screening which are amenable to standardized or non-standardized RQ-PCR quantification.
Required: ABL1 fusion
Evidence of typical BCR::ABL1 transcript or atypical transcripts at the time of Screening which are amenable to standardized or non-standardized RQ-PCR quantification.
Disease stage
Required: Stage CML-CP, CML-AP
CML-CP or CML-AP
Prior therapy
Must have received: tyrosine kinase inhibitor
history of documented T315I mutation after at least one TKI
Cannot have received: allosteric TKI (asciminib)
Not already treated with asciminib or another any allosteric TKI
Cannot have received: hematopoietic allogeneic stem-cell transplantation
Previous hematopoietic allogeneic stem-cell transplantation
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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