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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05456191 | A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) | PHASE3 | ACTIVE NOT_RECRUITING | 568 | — | — | Nov 21, 2022 | Jul 7, 2031 | May 27, 2026 | 120 | United States, Argentina +22 |
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due to AE within the specified timeframe is presented in the results table. The formal comparison between treatment arms is performed using a cause-specific hazard model, and the corresponding hazard ratio, confidence interval, and p-value are provided in the Statistical Analysis section. The TTDAE endpoint is event-driven by counting how many participants have experienced treatment discontinuations due to AE.
TTDAE is defined as the interval from the date of first study treatment administration to the date of discontinuation of study treatment due to an adverse event (AE). The comparison between the asciminib and nilotinib treatment arms is performed using a cause-specific hazard model, in which discontinuations due to AE are considered the event of interest and discontinuations for reasons other than AE are treated as competing risks. The number of participants who discontinued study treatment due to AE within the specified timeframe is presented in the results table. The formal comparison between treatment arms is performed using a cause-specific hazard model, and the corresponding hazard ratio, confidence interval, and p-value are provided in the Statistical Analysis section. The TTDAE endpoint is event-driven by counting how many participants have experienced treatment discontinuations due to AE.
| Arm | Type | Description |
|---|---|---|
| Asciminib | EXPERIMENTAL | Participants received asciminib 80 mg once a day (QD). |
| Nilotinib | ACTIVE_COMPARATOR | Participants will receive nilotinib 300 mg BID |
| Name | Type | Description |
|---|---|---|
| Asciminib | DRUG | Asciminib 80 mg QD administered under fasting conditions. |
| Nilotinib | DRUG | Nilotinib 300 mg twice a day (BID) was administered under fasting conditions. |
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Male or female patients ≥ 18 years of age. * Patients with CML-CP within 3 months of diagnosis. * Diagnosis of CML-CP (European Leukemia Network \[ELN\] 2020 criteria) with cytogenetic confirma...