DASATINIB for Chronic myeloid leukaemia

Inclusion criteria

• {"criterion_text":"- 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\n- Treated with TKI for at least one year after having failed a prior attempt to stop TKI. Previous TKI can be any.\n- Typical BCR/ABL1 transcript (b3a2 and/or b2a2) must have been confirmed at diagnosis or later during the disease course.\n- 18 years or older"}

Exclusion criteria

• {"criterion_text":"- Previous hematological relapse after first stop of TKI\n- A third stopping attempt\n- Previous AP/BC at any time in the history of the disease\n- Restart of TKI without loss of MMR after first stop\n- Current participation i another clinical study\n- Previous or planned allogeneic stem cell transplantation\n- Patients with contra-indications to dasatinib therapy due to comorbidities\n- Subjects with acute hepatitis B virus HBV) infections\n- Uncontrolled or significant cardiovascular disease\n- Pulmonary arterial hypertension\n- Pleural or pericardial effusions of any grade at study entry\n- History of significant bleeding disorder unrelated to CML"}

Primary endpoints

• {"endpoint_text":"- The proportion of patients maintaining MMR at 6 and 12 months after discontinuing TKI a second time (survival without loss of major molecular response, MMR, defined as BCR-ABL1>0.1% on IS at one time point).","definition_or_measurement_approach":"MMR defined as BCR-ABL1 > 0.1% on the International Scale (IS) at one time point; proportion maintaining MMR assessed at 6 and 12 months after TKI discontinuation."}

Secondary endpoints

• {"endpoint_text":"- Number of patients who re-achieved stable MR4, and were offered study participation; and overall and progression-free survival and the occurrence of a restart of TKI without prior molecular relapse.","definition_or_measurement_approach":"Stable MR4 (molecular response 4 log) attainment and counts; overall survival (OS) and progression-free survival (PFS) assessed; recording of TKI restarts without prior molecular relapse."}
• {"endpoint_text":"- Clinical and biological factors correlating with persistence of MMR or better after second TKI stop (BCR-ABL level before 2nd stop, Sokal score, gender, duration and type of TKI-treatment, duration of first TKI-stop, immunological biomarkers).","definition_or_measurement_approach":"Correlation analyses of clinical and biological variables (pre-stop BCR-ABL level, Sokal score, gender, TKI duration/type, duration of first stop, immunological biomarkers) with persistence of MMR."}
• {"endpoint_text":"- Time to reachievement of MR4 after second loss of MMR.","definition_or_measurement_approach":"Time-to-event analysis measuring interval from restart of therapy after second molecular relapse to re-achievement of MR4."}
• {"endpoint_text":"- Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs.","definition_or_measurement_approach":"Collection and analysis of adverse events occurring after second TKI stop and assessment of associated clinical/biological correlates."}

Netherlands

Earliest CTIS Part Ii Submission Date

06-09-2024

Latest Decision Or Authorization Date

17-09-2024

Processing Time Days

11

Number Of Sites

1

Number Of Participants

20

Denmark

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

27-01-2025

Processing Time Days

4

Number Of Sites

1

Number Of Participants

10

France

Earliest CTIS Part Ii Submission Date

06-09-2024

Latest Decision Or Authorization Date

23-09-2024

Processing Time Days

17

Number Of Sites

2

Number Of Participants

2

Primary sponsor

Full Name

Region Uppsala

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden

Third parties

• {"country":"","full_name":"Bristol-Myers Squibb","duties_or_roles":"Source of monetary support","organisation_type":""}