design, French, multicenter, open-label, stratified on the immunophenotypic characterization (B- or T- lineage) and the patient risk group, that aims at evaluating the efficacy and the tolerance of different schedules of pegaspargase in patients from 12 months to less than 18 years newly diagnosed with standard/medium-risk ALL, This is a prospective
Conditions
Brief summary
o Adequate asparaginase activity (>100 IU/L) at D33 of induction o Toxicity: Incidence of severe toxicities (Grade ≥ 3) directly asparaginaserelated (CNS thrombosis, pancreatitis, anaphylaxia, and hyperbilirubinemia) between D12 and D49 of treatment and anyway before D8 of consolidation
Detailed description
- to evaluate the incidence of rare subgroups of ALL and their prognostic value e.g. so-called “B-other” subgroup: BCR-ABL like (including EBF1-PDGFRB), MEF2D-X, ZNF384-X, TCF3-HLF… - 5 year EFS, DFS and OS of the rare patients with suboptimal response to therapy (induction failure or MRDTP1 ≥ 10-3) and ABL-class fusions ALLs treated with imatinib - Imatinib related adverse events in the rare patients with suboptimal response to therapy (induction failure
Interventions
DRUGPEGASPARGASE
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| o Adequate asparaginase activity (>100 IU/L) at D33 of induction o Toxicity: Incidence of severe toxicities (Grade ≥ 3) directly asparaginaserelated (CNS thrombosis, pancreatitis, anaphylaxia, and hyperbilirubinemia) between D12 and D49 of treatment and anyway before D8 of consolidation | — |
Secondary
| Measure | Time frame |
|---|---|
| - to evaluate the incidence of rare subgroups of ALL and their prognostic value e.g. so-called “B-other” subgroup: BCR-ABL like (including EBF1-PDGFRB), MEF2D-X, ZNF384-X, TCF3-HLF… - 5 year EFS, DFS and OS of the rare patients with suboptimal response to therapy (induction failure or MRDTP1 ≥ 10-3) and ABL-class fusions ALLs treated with imatinib - Imatinib related adverse events in the rare patients with suboptimal response to therapy (induction failure | — |
Countries
France
Outcome results
None listed