Study protocol for acute myeloid leukemia in children and adolescent

Study Protocol LAM 2013/01 - AIEOP LAM 2013/01

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000652-28-IT

Enrollment

300

Registered

2014-03-27

Start date

2015-02-04

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

pediatric patient with acute myeloid leukemia MedDRA version: 17.0 Level: LLT Classification code 10024349 Term: Leukemia myeloid System Organ Class: 100000004864

Interventions

Pharmaceutical Form: Solution for infusion INN or Proposed INN: cytarabine CAS Number: 147-94-4 Current Sponsor code: 1 Other descriptive name: CYTARABINE Concentration unit: mg/ml milligram(s)/millil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with LAM Patients aged between 0 and 18 years (17 years and 364 days) at diagnosis. Signed informed consent from the parents, or the legal representative of the child with the disease leukemia. Are the trial subjects under 18? yes Number of subjects for this age range: 300 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Down Syndrome Acute Promyelocytic leukemia (FAB M3) or t (15; 17) rearrangement with PML / RARa (Treatment Protocol ad hoc) AML secondary to MDS T-AML (therapy-related AML) Pregnancy or lactation in progress Pretreatment with anticancer or treatment with steroid drugs more than 7 days Organ dysfunctions

Design outcomes

Primary

Measure	Time frame
Main Objective: to obtain an event-free survival, EFS at 3 years after diagnosis 5% higher than that of the previous study;Secondary Objective: Reduce the proportion of early deaths (early death, ED), and deaths in complete remission Stratify patients according to new cytogenetic-molecular-biological criteria and based on the early response to the treatment groups in terms of evaluating the outcome Reduce the load therapeutic in 20% of patients will be allocated to the group Standard Risk (SR); Evaluate the effectiveness of a stratification that combines molecular lesions and clearance of MRD with a second course of induction with mitoxantrone ;Primary end point(s): to obtain an event-free survival, EFS at 3 years after diagnosis 5% higher than that of the previous study;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Main Objective: to obtain an event-free survival, EFS at 3 years after diagnosis 5% higher than that of the previous study;Secondary Objective: Reduce the proportion of early deaths (early death, ED), and deaths in complete remission Stratify patients according to new cytogenetic-molecular-biological criteria and based on the early response to the treatment groups in terms of evaluating the outcome Reduce the load therapeutic in 20% of patients will be allocated to the group Standard Risk (SR); Evaluate the effectiveness of a stratification that combines molecular lesions and clearance of MRD with a second course of induction with mitoxantrone ;Primary end point(s): to obtain an event-free survival, EFS at 3 years after diagnosis 5% higher than that of the previous study;Timepoint(s) of evaluation of this end point: 3 years

—

Secondary

Measure	Time frame
Secondary end point(s): Reduce the proportion of early deaths (early death, ED), and deaths in complete remission ;Timepoint(s) of evaluation of this end point: 5 years	—

Countries

Italy

Contacts

Public ContactAngela Mastronuzzi

Ospedale pediatrico Bambino Gesù

angela.mastronuzzi@opbg.net00390668592574

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Apr 22, 2026