Myeloid Leukemia in Children with Down Syndrome
Conditions
Brief summary
Event-free survival (EFS), defined as time from diagnosis to the first event or last follow-up. Events are death from any cause, failure to achieve remission, relapse, and secondary malignancy. Failure to achieve remission is considered as an event on day 0.
Detailed description
Overall survival (OS), as defined as the time of diagnosis to death from any cause or last follow-up, Disease-free survival (DFS), Early Response Rate (CR, CRp, CRi) after induction, Treatment-related mortality (TRM), Minimal residual disease (FACS and NGS), Adverse events (according to NCI CTCAE v4.0), Duration of myelosuppression (neutrophils <0.5 Gpt/L)
Sponsors
GPOH gGmbH
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS), defined as time from diagnosis to the first event or last follow-up. Events are death from any cause, failure to achieve remission, relapse, and secondary malignancy. Failure to achieve remission is considered as an event on day 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), as defined as the time of diagnosis to death from any cause or last follow-up, Disease-free survival (DFS), Early Response Rate (CR, CRp, CRi) after induction, Treatment-related mortality (TRM), Minimal residual disease (FACS and NGS), Adverse events (according to NCI CTCAE v4.0), Duration of myelosuppression (neutrophils <0.5 Gpt/L) | — |
Countries
Austria, Belgium, Czechia, Germany, Italy, Netherlands, Poland
Outcome results
None listed