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CHIP-AML22 Master Protocol for newly diagnosed pediatric de novo acute myeloid leukemia
2023-504999-25-00Phase 3Authorised
- Sponsor
- Princess Máxima Center for Pediatric Oncology
- Start
- Jul 2023
- Modality
- Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Nucleic Acid-Directed Small Molecules → Small Molecules
- Countries
- 16
01
Overview
Phase 3, randomised, open-label trial of gemtuzumab ozogamicin, cytarabine, daunorubicin, etoposide, fludarabine and 2 more in acute myeloid leukemia (AML) (5 arms), sponsored by Princess Máxima Center for Pediatric Oncology. Primary endpoints: Event-free survival, Measurable residual disease response before induction course 2 and 1 more. Planned start Jul 2023; status: authorised.
02
Drugs
gemtuzumab ozogamicincytarabinedaunorubicinetoposidefludarabine
03
Conditions
acute myeloid leukemia (AML)
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