Randomized Phase III Study of Standard Intensive Chemotherapy versus Intensive Chemotherapy with CPX-351 in Adult Patients with Newly Diagnosed AML and Intermediate- or Adverse Genetics

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503670-21-00

Acronym

AMLSG 30-18

Enrollment

842

Registered

2024-02-15

Start date

2019-08-28

Completion date

Unknown

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with newly diagnosed AML and intermediate- or adverse-risk genetics (according to 2017 ELN criteria), including AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML according to the World Health Organization (WHO) classification

Brief summary

Overall survival (OS) in the restricted set of de novo patients

Detailed description

Overall survival (OS) in the extended set of patients, Event-free survival (EFS) with CRi considered as response to induction therapy in both, the restricted set of de novo patients and the extended set of patients, Event-free survival (EFS) with CRi considered as failure of induction therapy in the restricted set of de novo patients, Rate of objective responses (complete remission [CR], CR with incomplete hematologic recovery [CRi], CRi without measurable residual disease [CRiMRD-], CR without measurable residual disease [CRMRD-]) in the restricted set of de novo patients

Interventions

DRUGCYTARABINE

DRUGDAUNORUBICIN

DRUGVyxeos Liposomal 44 mg/100 mg powder for concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS) in the restricted set of de novo patients	—

Secondary

Measure	Time frame
Overall survival (OS) in the extended set of patients, Event-free survival (EFS) with CRi considered as response to induction therapy in both, the restricted set of de novo patients and the extended set of patients, Event-free survival (EFS) with CRi considered as failure of induction therapy in the restricted set of de novo patients, Rate of objective responses (complete remission [CR], CR with incomplete hematologic recovery [CRi], CRi without measurable residual disease [CRiMRD-], CR without measurable residual disease [CRMRD-]) in the restricted set of de novo patients	—

Measure

Time frame

—

Countries

Austria, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026