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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04948333 | Asciminib Treatment Optimization in ≥ 3rd Line CML-CP | PHASE3 | COMPLETED | 199 | — | — | Oct 13, 2021 | Feb 25, 2026 | Mar 18, 2026 | 48 | Argentina, Austria +14 |
Major Molecular Response (MMR) is defined as a significant reduction in the level of BCR::ABL1 transcripts, which are the genetic markers of chronic myeloid leukemia (CML). Specifically, MMR is achieved when there is a ≥ 3.0 log reduction in BCR::ABL1 transcripts compared to a standardized baseline, which corresponds to a BCR::ABL1/ABL1 ratio of ≤ 0.1% on the international scale (IS). The Major Molecular Response (MMR) rate at Week 48 for all patients with no evidence of MMR at baseline refers to the percentage of patients who achieve MMR after 48 weeks of treatment, despite not having MMR at the start.
| Arm | Type | Description |
|---|---|---|
| ABL001 | EXPERIMENTAL | Participants will be treated with 80 mg of ABL001 (40 mg BID or 80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation. |
| Name | Type | Description |
|---|---|---|
| ABL001 40mg BID | DRUG | One tablet of 40 mg will be taken orally twice a day (BID) |
| ABL001 80mg QD | DRUG | Two tablets of 40 mg will be taken orally once a day (QD) |
| ABL001 200mg QD | DRUG | Five tablets of 40 mg will be taken orally once a day (QD) |
Key Inclusion criteria: * Signed informed consent must be obtained prior to participation in the study * Male or female patients with a diagnosis of CML-CP ≥ 18 years of age * Treatment with a minimum of 2 or more prior TKIs (i.e. imatinib, nilotinib, dasatinib, bosutinib, radotinib or ponatinib) *...