Phase III study to assess the impact of gemtuzumab ozogamicin, in combination with standard chemotherapy, on the levels of minimal residual disease, in adult patients, aged 18-60 years, with previously untreated, de novo, favorable- intermediate-risk acute myeloid leukemia. AML1819

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510433-29-00

Enrollment

414

Registered

2025-01-10

Start date

2020-09-24

Completion date

Unknown

Last updated

2025-01-10

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

Conditions

Favorable-intermediate-risk Acute Myeloid Leukemia

Brief summary

Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO

Detailed description

Overall Survival (OS) at 24 months, Event Free Survival (EFS) at 24 months, Cumulative incidence of relapse (CIR) at 24 months, Response rate in terms of patients who achieve CR after induction therapy, Safety in terms of number and type of adverse events (AE) and serious AE (SAE), OS, EFS, DFS and CIR in favorable and intermediate risk groups, OS, EFS, DFS and CIR according to the MRD level after induction and consolidation, Response rate, OS, EFS, DFS and CIR according to morphology, cytogenetic and molecular baseline characteristics.

Interventions

DRUGMYLOTARG 5 mg powder for concentrate for solution for infusion

DRUGDAUNORUBICIN HYDROCHLORIDE

DRUGFLUDARABINE

DRUGBUSULFAN

DRUGCYTARABINE

DRUGTREOSULFAN

DRUGCYCLOPHOSPHAMIDE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO	—

Secondary

Measure	Time frame
Overall Survival (OS) at 24 months, Event Free Survival (EFS) at 24 months, Cumulative incidence of relapse (CIR) at 24 months, Response rate in terms of patients who achieve CR after induction therapy, Safety in terms of number and type of adverse events (AE) and serious AE (SAE), OS, EFS, DFS and CIR in favorable and intermediate risk groups, OS, EFS, DFS and CIR according to the MRD level after induction and consolidation, Response rate, OS, EFS, DFS and CIR according to morphology, cytogenetic and molecular baseline characteristics.	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

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