Current and planned trials for children with newly diagnosed AML
| Trial . | Primary objectives . |
|---|---|
| St Jude AML16 (NCT03164057) | Safety and activity of epigenetic priming with DNA methyltransferase inhibitors |
| COG AAML1831 (NCT04293562) | Comparison of Vyxeos and GO vs daunorubicin, cytarabine, and GO as induction therapy |
| NOPHO-DBH AML-2012 (NCT01828489) | Comparison of daunorubicin/cytarabine/etoposide vs daunorubicin/cytarabine/fludarabine during induction II |
| Myechild01 (NCT02724163) | Induction: comparison of mitoxantrone/cytarabine with 1 vs 3 doses of gemtuzumab ozogamicin Consolidation: comparison of high-dose cytarabine vs fludarabine/cytarabine Conditioning at allo-HCT: comparison of busulfan/cyclophosphamide vs busulfan/fludarabine |
| NOPHO-DB-SHIP (planned) | Induction: comparison of mitoxantrone/etoposide/cytarabine with or without gemtuzumab ozogamicin Consolidation: comparison of 3 vs 2 courses in non-high-risk patients Conditioning at allo-HCT: comparison of busulfan/cyclophosphamide/melphalan vs busulfan/clofarabine/fludarabine |
| JPLSG-AML-20 (planned) | Phase 3 trial evaluating MRD-based risk stratification and a randomized study of GO in combination with postinduction consolidation chemotherapy for non–low-risk patients |
| AIEOP-BFM21 (planned) | Induction: comparison of 2 courses of Vyxeos vs idarubicin/cytarabine/etoposide followed by high-dose cytarabine/mitoxantrone Conditioning at allo-HCT: comparison of busulfan/cyclophosphamide/melphalan vs treosulfan/fludarabine/thiotepa |
| Trial . | Primary objectives . |
|---|---|
| St Jude AML16 (NCT03164057) | Safety and activity of epigenetic priming with DNA methyltransferase inhibitors |
| COG AAML1831 (NCT04293562) | Comparison of Vyxeos and GO vs daunorubicin, cytarabine, and GO as induction therapy |
| NOPHO-DBH AML-2012 (NCT01828489) | Comparison of daunorubicin/cytarabine/etoposide vs daunorubicin/cytarabine/fludarabine during induction II |
| Myechild01 (NCT02724163) | Induction: comparison of mitoxantrone/cytarabine with 1 vs 3 doses of gemtuzumab ozogamicin Consolidation: comparison of high-dose cytarabine vs fludarabine/cytarabine Conditioning at allo-HCT: comparison of busulfan/cyclophosphamide vs busulfan/fludarabine |
| NOPHO-DB-SHIP (planned) | Induction: comparison of mitoxantrone/etoposide/cytarabine with or without gemtuzumab ozogamicin Consolidation: comparison of 3 vs 2 courses in non-high-risk patients Conditioning at allo-HCT: comparison of busulfan/cyclophosphamide/melphalan vs busulfan/clofarabine/fludarabine |
| JPLSG-AML-20 (planned) | Phase 3 trial evaluating MRD-based risk stratification and a randomized study of GO in combination with postinduction consolidation chemotherapy for non–low-risk patients |
| AIEOP-BFM21 (planned) | Induction: comparison of 2 courses of Vyxeos vs idarubicin/cytarabine/etoposide followed by high-dose cytarabine/mitoxantrone Conditioning at allo-HCT: comparison of busulfan/cyclophosphamide/melphalan vs treosulfan/fludarabine/thiotepa |
AIEOP, Associazione Italiana di Ematologia e Oncologia Pediatrica; JPLSG, Japanese Pediatric Leukemia/Lymphoma Study Group; SHIP, Spain, Hong Kong, Israel, Portugal.