Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06514534 | Open-label Study of Asciminib for CML-CP or CML-AP Patients With T315I Mutation Who Are Resistant, Intolerant or Ineligible to Ponatinib. | PHASE2 | RECRUITING | 20 | — | — | Feb 18, 2025 | Feb 18, 2029 | Apr 21, 2026 | 6 | France |
Evaluation of asciminib efficacy : proportion of patients with MR2 (BCR::ABL1 IS ≤1%) level of response at 12 months.
| Arm | Type | Description |
|---|---|---|
| Asciminib (Scemblix®) | EXPERIMENTAL | Asciminib will be administered 200 mg twice a day orally. The minimum dose is 200 mg, and maximum dose is 400 mg. |
| Name | Type | Description |
|---|---|---|
| ABL001/Asciminib | DRUG | The study treatment for this clinical trial is an investigational drug called asciminib, which is marketed under the brand name Scemblix®. Asciminib is a compound that is being evaluated for its efficacy and safety in the treatment of the target condition. The minimum dose of asciminib to be administered in this study is 200 mg, while the maximum dose is 400 mg. The dose is planned as 200 mg twice a day (BID). The drug will be administered orally, allowing for convenient and non-invasive administration. |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female participants with a diagnosis of CML-CP or CML-AP ≥ 18 years of age. * Patients with CML-CP or CML-AP with history of documented T315I mutation after at least one TKI and are resista...