| Abstract: |
Up to 40% of newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) discontinue treatment by 5 years, primarily due to resistance or intolerance. Rates of resistance to second-line (2L) treatment are also high. Some patients with resistance respond with dose escalation of tyrosine kinase inhibitors (TKIs). Asciminib demonstrated safety and efficacy across a broad dosage range. ASC2ESCALATE is an ongoing, Phase II, multicenter, single-arm, dose-escalation study of asciminib in 2L and first-line treatment of CML-CP. The primary end point is major molecular response at 12 months in 2L. Secondary end points include molecular responses at and by scheduled time points, survival, and safety. ASC2ESCALATE is the first study investigating asciminib in CML-CP following failure of one prior TKI. Clinical Trial Registration:NCT05384587 (ClinicalTrials.gov). © 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. |
| Keywords: |
adult; treatment outcome; aged; middle aged; young adult; major clinical study; overall survival; clinical trial; drug tolerability; dose response; drug efficacy; drug safety; monotherapy; antineoplastic agents; antineoplastic agent; quality control; imatinib; progression free survival; phase 2 clinical trial; protein kinase inhibitor; creatinine; drug effect; drug resistance; pathology; dose-response relationship, drug; drug resistance, neoplasm; dasatinib; chronic myeloid leukemia; risk factor; protein tyrosine kinase inhibitor; drug dose escalation; protein kinase inhibitors; alanine aminotransferase; alkaline phosphatase; aspartate aminotransferase; hospitalization; pyrazole derivative; multicenter study; pyrazoles; real time polymerase chain reaction; drug therapy; toxicity; nilotinib; leukemia, myelogenous, chronic, bcr-abl positive; electrocardiogram; disease exacerbation; myeloid leukemia; nicotinamide; mmr; second-line treatment; leukemia, myeloid, chronic-phase; patient-reported outcome; bosutinib; chronic phase; dose escalation; first-line treatment; niacinamide; high throughput sequencing; second line; sanger sequencing; humans; human; male; female; article; asciminib; first line; asc2escalate; atrioventricular valve
|
