A multicenter trial where patients with CML stop medication a second time.

Phase 1

Conditions: Chronic Myeloid Leukemia
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2016-004106-34-FI

Lead Sponsor: ppsala University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 134

Inclusion Criteria

1.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 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 at-tempt 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

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 comor-bidities.
7.Subjects with acute hepatitis B virus (HBV) infections.
8.Uncontrolled or significant cardiovascular disease.
9. Pulmonary arterial hypertension
9.Pleural or pericardial effusions of any grade at study entry
11. History of significant bleeding disorder unrelated to CML