Chronic phase chronic myeloid leukemia Chronic phase Chronic myeloid leukemia CML-CP
Conditions
Interventions
None listed
Sponsors
Kikushige Yoshikane
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 18 years or older at the time of obtaining consent 2) Japanese patients with chronic phase chronic myeloid leukemia who meet the diagnostic criteria of the WHO classification revised 5th edition (2023) 3) Patients who are newly starting asciminib treatment 4) Patients with chronic myeloid leukemia who meet any of the following criteria at the time of enrollment TKI-naive Achievement of MMR but not MR4.5 with initial TKI therapy, and a minimum of 18 months of initial TKI treatment Initial TKI treatment did not respond well (however, this does not include patients with failure as defined by the TKI response evaluation category of the JSH guidelines) Intolerance of initial TKI treatment (excluding patients with treatment failure) 5) Female patients of childbearing potential who can consent to using highly effective contraception during the study 6) Patients who fully understand the study protocol and can give their own consent
Exclusion criteria
Exclusion criteria: 1) Patients who have been administered asciminib in the past 2) Patients who have been judged to have 'TKI failure' in the previous treatment recommended for ELN (2020) 3) Patients who achieved MR4.5 or higher with initial TKI treatment at the time of enrollment 4) Patients who have previously received two or more TKIs 5) Patients with severe renal dysfunction that may affect asciminib treatment 6) Patients with severe immune diseases or diseases that cause immunosuppression 7) Patients receiving immunosuppressant treatment 8) Patients who are unable to obtain appropriate understanding and consent due to psychiatric disorders, etc. 9) Patients who are participating in a clinical trial at the time of obtaining consent 10) Other patients who are judged by the Principal Investigator in medical institution (Sub Investigator) to be unable to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieved MR4.5 at 48 weeks after starting asciminib | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) MMR/MR4.0 achievement rate at 48 weeks and 96 weeks, EMR achievement rate (BCR::ABL1 transcription level is 10% or less of IS value) at 12 weeks, MR4.5 achievement rate at 96 weeks, and cumulative MMR/MR4.0/MR4.5 achievement rate by the end of the study 2) TFR achievement rate at 48 weeks after discontinuation of asciminib 3) Proportion of subjects who met the TFR eligibility criteria after asciminib treatment The proportion of subjects who selected TFR among those who met the TFR eligibility criteria 4) Type, frequency, and severity of adverse events during asciminib administration Proportion of treatment discontinuation and its reason Time to discontinuation of asciminib due to adverse events 5) Changes from baseline in overall and individual scores of QOL scales (MDASI-CML) during and after treatment discontinuation of asciminib | — |
Contacts
Public ContactMiyuki Yoshikawa
Kanazawa University Hospital
Outcome results
None listed