Myelodysplastic syndrome
Conditions
Brief summary
The percentage of clinical events defined as relapse or non-relapse death at 12 months from verified MRD positivity (NMDSG14B Part 2 compared to Part 1)
Detailed description
MRD positive cohort: Relapse-free survival, MRD positive cohort: GVHD and relapse-free survival, MRD positive cohort: Proportion of MRD positive subjects achieving MRD-negativity, MRD positive cohort: Incidence and severity of GVHD, MRD positive cohort: Safety in MRD positive subjects subjected to MRD-guided clinical intervention, Whole study cohort: Relapse-free survival, Whole study cohort: GVHD and relapse-free survival, Whole study cohort: Incidence and severity of GVHD, Whole study cohort: Overall survival
Interventions
DRUGAZACITIDINE
Sponsors
Karolinska University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of clinical events defined as relapse or non-relapse death at 12 months from verified MRD positivity (NMDSG14B Part 2 compared to Part 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD positive cohort: Relapse-free survival, MRD positive cohort: GVHD and relapse-free survival, MRD positive cohort: Proportion of MRD positive subjects achieving MRD-negativity, MRD positive cohort: Incidence and severity of GVHD, MRD positive cohort: Safety in MRD positive subjects subjected to MRD-guided clinical intervention, Whole study cohort: Relapse-free survival, Whole study cohort: GVHD and relapse-free survival, Whole study cohort: Incidence and severity of GVHD, Whole study cohort: Overall survival | — |
Countries
Denmark, Finland, Norway, Sweden
Outcome results
None listed