Acute Myeloid Leukemia
Conditions
Brief summary
Primary endpoint of overarching objective: Event-free survival (EFS), Primary end point induction Randomization: • MRD <0.1% leukemic cells in the BM, as defined by flow cytometry, shortly before start of induction course 2 (BM1)., Primary endpoint of consolidation Randomization: Disease-Free Survival (DFS)
Detailed description
Secondary end point overarching objective: • Bone marrow blast counts by morphology and multi-color flow cytometry (MFCM) after course #1 and #2 and before allo-SCT; ORR (CR, CRp, and CRi) and morphologic leukemia-free state (MLFS) rates after course #1 and #2; MRD negativity after course #1 and #2 and before allo-SCT; absolute MRD levels after course #1 and #2 and before allo-SCT. • OS • DFS • CIR., Secondary end point overarching objective: • Cumulative toxicity, defined as the total of all grades AEs over time, which are graded by NCI CTCAE version 5.0. • NRM., Secondary end point induction randomization: • Bone marrow blast counts by morphology and multi-color flow cytometry (MFCM) after course #1 and #2 and before allo-SCT; ORR (CR, CRp, and CRi) and morphologic leukemia-free state (MLFS) rates after course #1 and #2; MRD negativity after course #2 and before allo-SCT; absolute MRD levels after course and #2 and before allo-SCT. OS • DFS • EFS • CIR • OS, Secondary end point induction randomization: • Cumulative toxicity, defined as the total of grade ≥3 AESIs over time, which are graded by NCI CTCAE version 5.0. • Adverse events (AEs), as characterized by type, frequency, severity (as graded using CTCAE, v5.0). • Serious adverse events (SAEs), as characterized by type, frequency, severity (as graded using CTCAE, v5.0). • NRM., Secondary end point consolidation randomization: 18)• Cumulative toxicity, defined as the as the total of grade ≥3 AESIs over time, which are graded by NCI CTCAE version 5.0. 19)• Non-relapse mortality (TRM)., Secondary end point consolidation randomization: Cumulative Hospitalized Days, Secondary end point consolidation randomization: •OS •CIR
Interventions
DRUGDi-Adreson-F Aquosum 25 mg
DRUGpoeder voor oplossing voor injectie.
DRUGDaunorubicin 20mg Powder for I.V. Injection
DRUGCARDIOXANE 500 mg powder for solution for infusion
DRUGMethotrexate 2.5 mg/ml Injection
Sponsors
Prinses Maxima Centrum voor Kinderoncologie B.V.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of overarching objective: Event-free survival (EFS), Primary end point induction Randomization: • MRD <0.1% leukemic cells in the BM, as defined by flow cytometry, shortly before start of induction course 2 (BM1)., Primary endpoint of consolidation Randomization: Disease-Free Survival (DFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point overarching objective: • Bone marrow blast counts by morphology and multi-color flow cytometry (MFCM) after course #1 and #2 and before allo-SCT; ORR (CR, CRp, and CRi) and morphologic leukemia-free state (MLFS) rates after course #1 and #2; MRD negativity after course #1 and #2 and before allo-SCT; absolute MRD levels after course #1 and #2 and before allo-SCT. • OS • DFS • CIR., Secondary end point overarching objective: • Cumulative toxicity, defined as the total of all grades AEs over time, which are graded by NCI CTCAE version 5.0. • NRM., Secondary end point induction randomization: • Bone marrow blast counts by morphology and multi-color flow cytometry (MFCM) after course #1 and #2 and before allo-SCT; ORR (CR, CRp, and CRi) and morphologic leukemia-free state (MLFS) rates after course #1 and #2; MRD negativity after course #2 and before allo-SCT; absolute MRD levels after course and #2 and before allo-SCT. OS • DFS • EFS • CIR • OS, Secondary end point i | — |
Countries
Belgium, Denmark, Estonia, Finland, Iceland, Latvia, Lithuania, Netherlands, Norway, Portugal, Spain, Sweden
Outcome results
None listed