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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04971226 | A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP | PHASE3 | ACTIVE NOT_RECRUITING | 405 | — | — | Oct 6, 2021 | Jan 18, 2031 | Jun 8, 2026 | 110 | United States, Australia +27 |
Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL1/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
| Arm | Type | Description |
|---|---|---|
| Asciminib | EXPERIMENTAL | Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs |
| Investigator selected TKIs | ACTIVE_COMPARATOR | Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments: Imatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food |
| Name | Type | Description |
|---|---|---|
| Imatinib | DRUG | Comes in 100 mg and 400 mg tablets and taken orally |
| Nilotinib | DRUG | Comes in 150 mg and 200 mg capsules and taken orally |
| Bosutinib | DRUG | Comes in 100 mg and 400 mg tablets and taken orally |
| Dasatinib | DRUG | Comes in 20 mg, 50 mg, 70 mg and 100 mg tablets and taken orally |
| Asciminib | DRUG | Comes in 40 mg tablets and taken orally |
Inclusion Criteria for treatment period: Participants eligible for inclusion in this study must meet all of the following criteria: * Male or female patients ≥ 18 years of age. * Participants with CML-CP within 3 months of diagnosis. * Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confi...