A multicenter trial where patients with CML stop medication a second time.
Key facts
- Where
- Lille Cedex és Paris Cedex 10, FranciaországSee the 2 sites
- Phase
- 2. fázis
Where in Franciaország
- Centre Hospitalier Universitaire De LilleLille Cedex, FranciaországTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Region Uppsala
- Trial code
- EU 2024-515409-25-00
- Record updated
- 2025. március 3.
- Original description
Assessment of treatment-free remission (persistence of MMR) after second attenmpt of TKI discontinuation in patients who failed a relapse in the EURO-SKI study or under EURO-SKI like conditions. Patients must have received at least three years of further TKI treatment of which the two last years should be dasatinib. The patients must have been in MR4 for a least one year.Read full original descriptionShow less
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. DASTOP2 TRIAL
Assessment of treatment-free remission (persistence of MMR) after second attenmpt of TKI discontinuation in patients who failed a relapse in the EURO-SKI study or under EURO-SKI like conditions. Patients must have received at least three years of further TKI treatment of which the two last years should be dasatinib. The patients must have been in MR4 for a least one year.
Inclusion: CML in 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 stop, and MR4 for at least one year before stopping; Treated with TKI for at least one year after having failed a prior attempt to stop TKI. Previous TKI can be any; Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course; 18 years or older.
Exclusion: Previous hematological relapse after first stop of TKI; Previous AP/BC at any time in the history of the disease; Previous or planned allogeneic stem cell transplantation; Patients with contra-indications to dasatinib therapy due to comorbidities; History of significant bleeding disorder unrelated to CML; Subjects with acute hepatitis B virus HBV) infections; Uncontrolled or significant cardiovascular disease; Pulmonary arterial hypertension; Pleural or pericardial effusions of any grade at study entry; A third stopping attempt; Restart of TKI without loss of MMR after first stop; Current participation i another clinical study.