Clinical trial · Interventional
Persistence of MR3 in Chronic Myeloid Leukemia (CML) After a 2nd Stop of TKI Treatment
Persistence Of Major Molecular Remission In Chronic Myeloid Leukemia After A Second Stop Of Tki Treatment In Patients Who Failed An Initial Stop Attempt: A Multicenter Prospective Trial
- 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)
This study will enroll CML patients who have failed a first TKI stopping attempt. After failure and at least a year of TKI treatment, patients will proceed to dasatinib treatment for another 2 years. If MR4 or better is re-achieved and maintained for at least one year, patients will be eligible for a second stop. After verification of MR4, TKI treatment will be stopped and patients followed in the same manner as after first stop. If MMR is lost (BCR-ABL \>0.1% (IS)), TKI treatment will once again be restarted.
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 |
|---|---|---|---|
| CML, Relapsed | Chronic Myeloid Leukemia, BCR-ABL1 Positive | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- dasatinib
- description
- 2 years of dasatinib treatment before discontinuation if MR 4 is achieved for at least 1 year
- interventionNames
- Drug: Dasatinib
Primary outcomes (1)
- measure
- successful MMR maintenance
- timeFrame
- one year
- description
- The proportion of patients maintaining MMR at 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1 \> 0.1% on IS at one time point).
Secondary outcomes (7)
- measure
- correlates with succesful stop
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. CML in chronical phase (CP) under TKI treatment after failing a prior attempt to stop treatment within EURO-SKI or outside the study but according to EURO-SKI trial procedures. For the latter group this requires at least 3 years of TKI treatment (first line or second line due to intolerance to first line) before first stop, and MR4 for at least one year before stopping. 2. Treated with TKI for at least one year after having failed a prior attempt to stop TKI. Previous TKI can be any. 3. Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course. 4. 18 years or older. Exclusion Criteria: 1. Previous hematological relapse after first stop of TKI. 2. Previous AP/BC at any time in the history of the disease. 3. Restart of TKI without loss of MMR after first stop 4. Current participation in another clinical study. 5. Previous or planned allogeneic stem cell transplantation. 6. Patients with contra-indications to dasatinib therapy due to comorbidities. 7. Subjects with acute hepatitis B virus (HBV) infections. 8. Uncontrolled or significant cardiovascular disease. 9. Pulmonary arterial hypertension. 10. Pleural or pericardial effusions of any grade at study entry are excluded 11. History of significant bleeding disorder unrelated to CML 12. Hypersensitivity to dasatinib and excipients of dasatinib tablets.
References
Publications (1)
- DERIVEDFlygt H, Soderlund S, Richter J, Saussele S, Koskenvesa P, Stenke L, Mustjoki S, Dimitrijevic A, Stentoft J, Majeed W, Roy L, Wolf D, Dreimane A, Gjertsen BT, Gedde-Dahl T, Ahlstrand E, Markevarn B, Hjorth-Hansen H, Janssen J, Olsson-Stromberg U. Treatment-free remission after a second TKI discontinuation attempt in patients with Chronic Myeloid Leukemia re-treated with dasatinib - interim results from the DAstop2 trial. Leukemia. 2024 Apr;38(4):781-787. doi: 10.1038/s41375-024-02145-6. Epub 2024 Jan 26. PMID 38278960