chronic myeloid leukemia in chronic phase
Conditions
Brief summary
MR4 after 24 months of ponatinib treatment
Detailed description
Molecular status (no MMR, MMR, MR4, and MR4.5) at the evaluation times defined in the visit schedule, Time from inclusion to first MR4 and to first MR4.5, Safety profile, tolerability and adverse events under ponatinib treatment, Health-related quality of life (QoL) under ponatinib treatment, Identification of clinical and biological factors associated with the achievement of MR4 or better under ponatinib (e.g. risk scores (Sokal/Euro/EUTOS/ ELTS), gender, duration of TKI treatment, molecular level at study entry, Evaluation of medico-economic impact of ponatinib therapy with the possibility of a TFR approach, Evaluation of overall survival and progression-free survival
Interventions
Sponsors
Heidelberg University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MR4 after 24 months of ponatinib treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Molecular status (no MMR, MMR, MR4, and MR4.5) at the evaluation times defined in the visit schedule, Time from inclusion to first MR4 and to first MR4.5, Safety profile, tolerability and adverse events under ponatinib treatment, Health-related quality of life (QoL) under ponatinib treatment, Identification of clinical and biological factors associated with the achievement of MR4 or better under ponatinib (e.g. risk scores (Sokal/Euro/EUTOS/ ELTS), gender, duration of TKI treatment, molecular level at study entry, Evaluation of medico-economic impact of ponatinib therapy with the possibility of a TFR approach, Evaluation of overall survival and progression-free survival | — |
Countries
Germany
Outcome results
None listed