2024-515409-25-00RecruitingPhase 2
A multicenter trial where patients with CML stop medication a second time.
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 27 Aug 2024
- Start date
- 11 Jan 2018
- Lead sponsor
- Region Uppsala
- Diseases
- Chronic myeloid leukaemia
- EU CT number
- 2024-515409-25-00
- EudraCT number
- 2016-004106-34
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 32
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- History of significant bleeding disorder unrelated to CML
- Subjects with acute hepatitis B virus HBV) infections
- Uncontrolled or significant cardiovascular disease
- Pulmonary arterial hypertension
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Midtjylland | Aarhus N | Denmark | Recruiting |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 10 | France | Recruiting |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.