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 (Jun 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
Treatments studied
Targeted therapy
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
Demographics
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.
Frequently asked questions
Is NCT06514534 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allosteric TKI, hematopoietic allogeneic stem-cell transplantation disqualifies patients from enrollment.
Does this trial require ABL1?
Yes, ABL1 T315I is a required biomarker for enrollment.
Does this trial require BCR?
Yes, BCR fusion is a required biomarker for enrollment.
Does this trial require ABL1?
Yes, ABL1 fusion is a required biomarker for enrollment.
What disease stage is eligible?
Stage CML-CP or CML-AP is required.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify