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

Recruiting

Conditions: Chronic myeloid leukemia
10024324

Registration Number: NL-OMON46534

Lead Sponsor: ppsala University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The proportion of patients maintaining MMR at 6 and 12 months after<br /><br>discontinuing TKI a second time (survival without loss of major molecular<br /><br>response, MMR, defined as BCR-ABL1 > 0.1% on IS at one time point).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Assessment of:<br /><br>1. Clinical and biological factors correlating with persistence of MMR or<br /><br>better after second TKI stop (BCR-ABL level before 2nd stop, Sokal score,<br /><br>gender, duration and type of TKI-treatment, duration of first TKI-stop,<br /><br>immunological biomarkers)<br /><br>2. Number of patients who re-achieved stable MR4, and were offered study<br /><br>participation;.and Overall and progression-free survival and the occurrence of<br /><br>a restart of TKI without prior molecular relapse.<br /><br>3. Time to reachievement of MR4 after second loss of MMR.<br /><br>4. Adverse events related to second TKI stop, clinical and biological factors<br /><br>correlated to development of these AEs.</p><br>