The purpose of the present study is to determine the rate of successful treatment-free remission (TFR) within the first 52 weeks following cessation of ponatinib treatment in patients who achieved MR4. Eligible patients had been previously treated with TKI and when patients achieved an optimal molecular response, TKI treatment was discontinued. After loss of response, patients were treated again with a TKI treatment and have documented MR4 for one year at the time of switch to ponatinib to study entry. MR4 is defined as BCR-ABL transcript level ≤ 0.01% IS or undetectable BCR-ABL levels with sample sensitivity of at least 4 log.
Name: Ponatinib 15 MG
Name: Acetylsalicylic acid 100 MG
Description: This variable is defined as the number of patients who have a maintained MMR and have not restarted TKI therapy in the first 52 weeks after starting ponatinib TFR phase divided by the number of patients who entered ponatinib TFR phase.
Measure: Proportion of patients with a maintained MMR within 52 weeks following ponatinib Treatment-Free Remission (TFR) Time: 52 weeksDescription: The number and percentage of patients with treatment-emergent adverse events (new or worsening from baseline) will be summarized by system organ class (SOC) and/or preferred term (PT), severity (based on CTCAE grades), type of adverse event and relation to study treatment.
Measure: Evaluate the toxicity and safety profile of 15 mg/24h dose treatment of ponatinib combined with ASA. Time: 104 weeksDescription: The number and percentage of patients with thromboembolic events will be summarized by preferred term, severity (based on CTCAE grades), type of adverse event, relation to study treatment by the phases or subsets previously described.
Measure: Evaluate thromboembolic events for study period. Time: 104 weeksDescription: The number and percentage of patients with hemorrhagic events will be summarized by preferred term, severity (based on CTCAE grades), type of adverse event, relation to study treatment by the phases or subsets previously described.
Measure: Evaluate hemorrhagic events for study period. Time: 104 weeksDescription: The number and percentage of patients with hemolytic events will be summarized by preferred term, severity (based on CTCAE grades), type of adverse event, relation to study treatment by the phases or subsets previously described.
Measure: Evaluate hemolytic events for study period. Time: 104 weeksDescription: The number and percentage of patients with gastrointestinal events will be summarized by preferred term, severity (based on CTCAE grades), type of adverse event, relation to study treatment by the phases or subsets previously described.
Measure: Evaluate gastrointestinal events for study period. Time: 104 weeksDescription: Number of patients still in MR4 and have not restarted TKI therapy in the first 52 weeks after starting ponatinib TFR phase divided by the number of patients who entered ponatinib TFR phase.
Measure: Evaluate the proportion of patients still in MR4 (BCR-ABL ≤ 0.01%) within 52 weeks following ponatinib therapy cessation. Time: 52 weeksDescription: The number of patients who still have a MMR and have not restarted TKI therapy in the first 24 weeks after starting ponatinib TFR phase divided by the number of patients who entered ponatinib TFR phase.
Measure: Evaluate the proportion of patients still in MMR within 24 weeks following ponatinib therapy cessation. Time: 24 weeksDescription: Number of patients with each clinical response obtained after stop Ponatinib treatment classified with subject´s physical activity frequency during 52 weeks
Measure: Evaluate the effects of physical activity on treatment response Time: 52 weeksDescription: Time from start ponatinib treatment to the occurrence of progression to AP/BC, loss of MMR or death from any cause, the earliest of these events.
Measure: To estimate progression-free survival (PFS) Time: 4 yearsDescription: time from ponatinib cessation to the occurrence of loss of MMR, restart of TKI treatment, progression of AP/BC, or death from any cause, the earliest of these events.
Measure: Treatment-free survival (TFS) Time: 104 weeksDescription: The number of patients who achieve a MR 5 at ponatinib therapy cessation divided by the number of patients who entered ponatinib TFR phase.
Measure: Evaluate the proportion of patients who achieve a MR 5 at ponatinib therapy cessation. Time: 104 weeksAllocation: N/A
Single Group Assignment
There are 4 SNPs
3. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past). --- T315I --- --- E255K ---
3. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past). --- T315I --- --- E255K --- --- Y253H --- --- F359C ---
3. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past). --- T315I ---
3. CML treatment resistant mutation(s) (T315I, E255K/V, Y253H, F359C/V) detected if a testing was done in the past (there is no requirement to perform mutation testing at study entry if it was not done in the past). --- T315I --- --- E255K --- --- Y253H ---