Acute Myeloid Leukemia (Pediatric 0-18 years)
Conditions
Brief summary
The fraction of patients who achieve an MRD level below 0.1%, as quantified by flow cytometry, after the first induction course. (aim 1), The fraction of patients who achieve an MRD level below 0.1%, as quantified by flow cytometry, after the second induction course (aim 2), For patients with fusion genes MRD levels after course 1 and 2 (aim 3)
Detailed description
Event-free survival and overall survival at five years, The median MRD after course 1 and course 2., The rate of CR after one and two induction courses., Cardiac function after one and five years., Frequency of severe adverse events as defined in section 14.2.3 in the protocol, early deaths and deaths in CR
Interventions
DRUGETOPOSIDE
DRUGCYTARABINE
DRUGDAUNORUBICIN
DRUGDAUNORUBICIN HYDROCHLORIDE
DRUGMITOXANTRONE
DRUGFLUDARABINE PHOSPHATE
Sponsors
Vaestra Goetalandsregionen
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The fraction of patients who achieve an MRD level below 0.1%, as quantified by flow cytometry, after the first induction course. (aim 1), The fraction of patients who achieve an MRD level below 0.1%, as quantified by flow cytometry, after the second induction course (aim 2), For patients with fusion genes MRD levels after course 1 and 2 (aim 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival and overall survival at five years, The median MRD after course 1 and course 2., The rate of CR after one and two induction courses., Cardiac function after one and five years., Frequency of severe adverse events as defined in section 14.2.3 in the protocol, early deaths and deaths in CR | — |
Countries
Belgium, Denmark, Finland, Netherlands, Norway, Spain, Sweden
Outcome results
None listed