Acute Myeloid Leukemia At Initial Diagnosis and/or Relapse in Children, Teenagers and Young Adults: Molecular Profiling, Multidrug Testing and MSC Interaction Studies

Cumulative incidence of relapse (CIR) from remission status.

Relapse is defined as: Bone marrow blasts ≥ 5% and/or evidence of extramedullary disease

Time frame: Up to 5 years

Event Free Survival (EFS)

Event Free Survival (EFS) is defined as the time from start of chemotherapy to failure, relapse, or death which ever occurs first

Time frame: Up to 5 years

Disease Free Survival (DFS)

Disease Free Survival (DFS) is defined as the time from remission status to relapse or death.

Time frame: Up to 5 years

Number of mutations identified by WGS

Number of mutations identified by Whole-Genome-Sequencing (WGS) as compared to Next-Generation Sequencing (NGS) in leukemic cells

Time frame: Up to 5 years

Expression profile (transcriptome) of mesenchymal stem cells

Expression profile (transcriptome) of mesenchymal stem cells at AML diagnosis and relapse compared to age matched controls without AML

Time frame: Up to 5 years

Engraftment rate of primary leukemic cells

Engraftment rate of primary leukemic cells in Patient-derived xenografts (PDX) or other experimental models

Time frame: Up to 5 years

Matched rate of genetic mutational (or expression) profile between derived cells from experimental models to primary leukemic cells

Time frame: Up to 5 years

Comparison of LSC signature profile of leukemic primary blasts at diagnosis and at relapse

Time frame: Up to 5 years

Cumulative incidence of relapse according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse

Cumulative incidence of relapse according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

Time frame: Up to 5 years

EFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse

Event Free Survival according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

Time frame: Up to 5 years

DFS according to LSC signature profile of leukemic primary blasts at diagnosis and at relapse

Disease-Free Survival (DFS) according to Leukemic Stem Cell (LSC) signature profile of leukemic primary blasts at diagnosis and at relapse

Time frame: Up to 5 years

Ex vivo multidrug testing profile of leukemic primary blasts

Comparison of ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Time frame: Up ot 5 years

Cumulative incidence of relapse according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Time frame: Up to 5 years

EFS according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Event-Free Survival according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Time frame: Up to 5 years

DFS according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Disease Free Survival according to ex vivo multidrug testing profile of leukemic primary blasts at diagnosis and relapse

Time frame: Up to 5 years

Mutational profile of patients

Comparison of mutational profile of patients with a predisposition syndrome compared to mutational profile of patients with AML at diagnosis and relapse

Time frame: Up ot 5 years

Percentage of MRD clearance

MRD clearance is defined as MRD below 10-3 Evaluated by flow cytometry and high sensitivity NGS (defined as MRD below 10-4) after each chemotherapy course

Time frame: Up to 5 years

Cumulative incidence of relapse according to MRD clearance

Evaluated by flow cytometry at a sensitivity threshold of 10-3

Time frame: Up to 5 years

EFS according to MRD clearance

Evaluated by flow cytometry at a sensitivity threshold of 10-3

Time frame: Up to 5 years

DFS according to MRD clearance

Evaluated by flow cytometry at a sensitivity threshold of 10-3

Time frame: Up to 5 years

Cumulative incidence of relapse according to MRD clearance

Evaluated by high sensitivity NGS at a threshold of 10-4

Time frame: Up to 5 years

EFS according to MRD clearance

Evaluated by high sensitivity NGS at a threshold of 10-4

Time frame: Up to 5 years

DFS according to MRD clearance

Evaluated by high sensitivity NGS at a threshold of 10-4

Time frame: Up to 5 years