Chronic myeloid leukemia
Conditions
Brief summary
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).
Detailed description
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., 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)., Time to reachievement of MR4 after second loss of MMR., Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs.
Interventions
Sponsors
Region Uppsala
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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., 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)., Time to reachievement of MR4 after second loss of MMR., Adverse events related to second TKI stop, clinical and biological factors correlated to development of these AEs. | — |
Countries
Denmark, France, Netherlands
Outcome results
None listed