None listed
Conditions
Interventions
Drug : ? Asciminib (80mg qd for nilotinib
60mg qd for imatinib
80mg qd for dasatinib) will be added at 12 weeks after the re-initiation of TKIs.
? Patients will be dropped out from this study if patients are intolerant to asciminib 20mg qod or loss of MR3.0 occur
Sponsors
Gachon University Gil Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 19 year or older 2. CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more 3. Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs. 4. Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening 5. Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure 6. Patients who agree with stopping TKIs after maintaining 3 year-duration of MR4.5 7. Adequate end organ function as defined by: • Total bilirubin (TBL) ULN - = 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis 8. Patients who can sign the informed consent of their own free will
Exclusion criteria
Exclusion criteria: 1. Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib). 2. Patients who are receiving any other investigational agents. 3. Patients who currently have uncontrolled infections 4. Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy. 5. Patients with clinically significant cardiovascular disease or gastrointestinal dysfunction. 6. Patients who have a history of thromboembolic episodes within 3 months prior to the study enrollment. 7. Patients with active hepatitis B or C with uncontrolled disease activity. 8. Patients who have active malignancies requiring treatment other than CML. 9. Patients with any severe and/or uncontrolled medical conditions or other conditions that could adversely impact on patients’ ability to participate in the study. 10. Patients with psychiatric illness/social situations that would limit compliance with study requirements. 11. Pregnant women are excluded from this study Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with asciminib and TKIs, breastfeeding should be discontinued if the mother is treated with asciminib and TKIs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the cumulative incidence of sustained MR3.0 or less by 1 year of cessation of TKI and asciminib | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the re-achievement rate of MR4.5 adding asciminib on TKI;To evaluate molecular relapse-free survival (MRFS), overall survival (OS), time to loss of MR3.0/4.0/4.5, and treatment-free survival (TFS);To evaluate safety profiles of additional asciminib on TKI;To analyze prognostic factors to predict the successful TFR after combination therapy of asciminib and TKI | — |
Countries
Korea, Republic of
Contacts
Public ContactEunju park
Gachon University Gil Medical Center
Outcome results
None listed