Clinical trial · Interventional
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia in Combination With Asciminib and Tyrosine Kinase Inhibitors
NCT06368414CI-TRIAL-00107107AsterArecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia, Chronic Phase | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Asciminib | Drug | Asciminib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Asciminib arm
- interventionNames
- Drug: Asciminib
Primary outcomes (1)
- measure
- MR3.0 or less by 1 year
- timeFrame
- by 1 year
- description
- To evaluate the cumulative incidence of sustained MR3.0 or less by 1 year of cessation of TKI and asciminib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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 asciminib and TKIs after maintaining 23 year-duration of MR4.5 7. Adequate end organ function as defined by: * Total bilirubin (TBL) \< 3 x upper limit of normal (ULN); patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN * Creatinine clearance (ClCr) ≥ 30 mL/min as calculated using Cockcroft-Gault formula * Serum lipase ≤ 1.5 x ULN. For serum lipase \> 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: 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.
References
Publications (1)
- BACKGROUNDLevey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54. doi: 10.7326/0003-4819-145-4-200608150-00004. PMID 16908915