chronic myeloid leukemia
Conditions
Brief summary
Proportion of patients in major molecular response (MMR) ie BCR-ABL1 (oncogenic BCR-ABL gene fusion transcript levels <= 0.1%) and Molecular Recurrence-Free Survival (MRFS, ie time from study entry to MMR loss, ie BCR-ABL1 transcript levels > 0.1% in 2 consecutive samples, or death from any cause) at month 6 after study entry, Proportion of patients in major molecular response (MMR) and MRFS at month 12 after study entry, Proportion of patients in MMR without treatment (TFR) and treatment-free survival (TFS, ie the time from withdrawal of TKI (tyrosin kinase inhibitors) to loss of MMR, reinitiation of TKI therapy from any cause, progression, or death from any cause) at month 18, 24 and 36 after study entry, ie, 6, 12 and 24 months after treatment discontinuation
Detailed description
Proportion of patients who lose MMR during de-escalation and in whom MMR and MR4.0 will recover after TKI re-introduction, Proportion of patients who lose MMR after discontinuation of TKI and in whom MMR and MR4.0 will recover after TKI re-introduction, Time to re-establish MMR and MR4.0 after TKI restart, Assessment of TKI's adverse effects dynamics during two-step reduction of their dose before withdrawal, Assessment of TKI withdrawal syndrome (proportion of patients with development of withdrawal syndrome, severity of symptoms, time to first complaint, duration of complaints, therapeutic intervention), Assessment of the correlation between adverse effects on previous TKI treatment and possible withdrawal syndrome, Correlation of BCR-ABL1 kinetics (number of BCR-ABL1 transcripts in time) during TKI therapy with potential molecular relapse after TKI discontinuation, Correlation of the effect of TKI dose reduction and subsequent discontinuation with lipid metabolism and glycemia
Interventions
Sponsors
Masarykova Univerzita
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients in major molecular response (MMR) ie BCR-ABL1 (oncogenic BCR-ABL gene fusion transcript levels <= 0.1%) and Molecular Recurrence-Free Survival (MRFS, ie time from study entry to MMR loss, ie BCR-ABL1 transcript levels > 0.1% in 2 consecutive samples, or death from any cause) at month 6 after study entry, Proportion of patients in major molecular response (MMR) and MRFS at month 12 after study entry, Proportion of patients in MMR without treatment (TFR) and treatment-free survival (TFS, ie the time from withdrawal of TKI (tyrosin kinase inhibitors) to loss of MMR, reinitiation of TKI therapy from any cause, progression, or death from any cause) at month 18, 24 and 36 after study entry, ie, 6, 12 and 24 months after treatment discontinuation | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who lose MMR during de-escalation and in whom MMR and MR4.0 will recover after TKI re-introduction, Proportion of patients who lose MMR after discontinuation of TKI and in whom MMR and MR4.0 will recover after TKI re-introduction, Time to re-establish MMR and MR4.0 after TKI restart, Assessment of TKI's adverse effects dynamics during two-step reduction of their dose before withdrawal, Assessment of TKI withdrawal syndrome (proportion of patients with development of withdrawal syndrome, severity of symptoms, time to first complaint, duration of complaints, therapeutic intervention), Assessment of the correlation between adverse effects on previous TKI treatment and possible withdrawal syndrome, Correlation of BCR-ABL1 kinetics (number of BCR-ABL1 transcripts in time) during TKI therapy with potential molecular relapse after TKI discontinuation, Correlation of the effect of TKI dose reduction and subsequent discontinuation with lipid metabolism and glycemia | — |
Countries
Czechia
Outcome results
None listed