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Taking people in DenmarkPhase 2

Tests a second attempt to stop leukemia medicine in people with chronic myeloid leukemia

Tests whether adults with chronic myeloid leukemia stay well after a second stop of medicine.

Key facts

Who runs it
Region Uppsala
Where
Aarhus N, DenmarkSee the siteAlso in 2 other countries, 3 sites
Registry title
A multicenter trial where patients with CML stop medication a second time.
Status
Recruiting
Phase
Phase 2
People taking part
32 people, planned
Started
11 Jan 2018
Expected to end
31 Dec 2026
Type of study
Interventional
Record updated
3 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic myeloid leukemia in chronic phase who failed a first attempt to stop TKI treatment and are now trying to stop a second time.

Age
18 years or older
Sex
All sexes
Disease stage
Chronic myeloid leukemia in chronic phase (CP). No earlier accelerated or blast phase at any time.
Earlier treatment
Failed a first attempt to stop TKI treatment (in the EURO-SKI study or under EURO-SKI trial procedures). Then at least 1 year of TKI treatment after that failed stop. Outside the study: at least 3 years of TKI treatment before the first stop, and MR4 for at least one year before stopping. The summary says the last 2 years of treatment should be dasatinib.
Biomarker or test result
Typical BCR/ABL1 transcript (b3a2 and/or b2a2) confirmed at diagnosis or later. MR4 for at least one year before stopping.

Main reasons for not taking part

  • Hematological relapse after the first TKI stop
  • Pleural or pericardial effusions of any grade at study entry
  • Allogeneic stem cell transplantation, previous or planned
  • Previous accelerated or blast phase of the disease
  • Contra-indications to dasatinib because of other illnesses

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Denmark

Also in 2 other countries, 3 sites

  • Region MidtjyllandAarhus N, DenmarkTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests a second attempt to stop leukemia medicine in people with chronic myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
3 March 2025