Phase 3
Completed N=199
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP
Source: ClinicalTrials.gov NCT04948333 ↗Enrolled (actual)
199
Serious AEs
13.6%
Results posted
Mar 2025
Primary outcomePrimary: Major Molecular Response (MMR) Rate at Week 48 for All Patients With no Evidence of MMR at Baseline — 42.35; 34.52 Percentage of responders
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Molecular Response (MMR) Rate at Week 48 for All Patients With no Evidence of MMR at Baseline |
42.35; 34.52 | — |
| SECONDARY MMR Rate at Week 12, 24, 36, 72, 96 and 144 for Patients With no MMR at Baseline |
— | — |
| SECONDARY Major Molecular Response (MMR) Rate at Week 48 for Patients With MMR at Baseline |
100; 87.5 | — |
| SECONDARY Time to MMR for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Rate of BCR::ABL1 ≤ 10% for Subjects Without MMR at Baseline |
69.4; 81.0; 72.9; 76.2; 71.8; 82.1 | — |
| SECONDARY Rate of BCR::ABL1 ≤ 1% for Subjects Without MMR at Baseline |
61.2; 53.6; 64.7; 58.3; 63.5; 64.3 | — |
| SECONDARY Deep Molecular Responses (MR4) Rate for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Deep Molecular Responses (MR4.5) Rate for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Rate of Complete Cytogenetic Response (CCyR) for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Occurrence of High-risk Additional Chromosomal Abnormalities (ACA) for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Cumulative Molecular Response Rate of BCR::ABL1 ≤ 10% for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Cumulative Molecular Response Rate of BCR::ABL1 ≤1% for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Cumulative Molecular Response Rate of MMR for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Cumulative Molecular Response Rate of MR4 for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Cumulative Molecular Response Rate of MR4.5 for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Duration of MMR |
— | — |
| SECONDARY Duration of MR4 Without Loss of MMR |
— | — |
| SECONDARY Progression-Free Survival (PFS) for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Overall Survival (OS) for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Time to Treatment Failure (TTF) for Subjects Without MMR at Baseline |
— | — |
| SECONDARY Change in Symptom Burden and Interference From Baseline Over Time According to the MDASI-CML PRO Instrument |
— | — |
Eligibility Criteria
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)
- Warning or failure (adapted from the 2020 ELN Recommendations) or intolerance to the most recent TKI therapy at the time of screening
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
- Adequate end organ function (as per central laboratory tests)
Key Exclusion criteria
- Known presence of the BCR: :ABL1 T315I mutation at any time prior to study entry
- Known second chronic phase of CML after previous progression to AP/BC
- Previous treatment with a hematopoietic stem-cell transplantation
- Patient planning to undergo allogeneic hematopoietic stem cell transplantation
- Uncontrolled cardiac repolarization abnormality
- Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol
- History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
- Testing for Hepatitis B surface antigen (HbsAg) and Hepatitis B core antibody (HBcAb / anti HBc) will be performed at screening. Patients with active Hepatitis B Virus (HBV) infection (hepatitis B surface antigen [HbsAg] positive) will be excluded
Other Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04948333). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.