AML-BFM 2012: clinical trial for the treatment of acute myeloid leukemia in children and adolescents

AML-BFM 2012: clinical trial for the treatment of acute myeloid leukemia in children and adolescents - an open prospective randomized phase III trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN78830591

Enrollment

448

Registered

2013-03-25

Start date

2013-07-01

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

Pediatric acute myeloid leukemia Cancer Acute myeloblastic leukaemia

Interventions

In total 500 patients will be recruited with study duration of 5 years and estimated 100 patients randomised per year. Randomisation 1: 448 Patients till the end 2017, randomisation 2: 380 Patients ti

40mg/m2

5 days) Arm B: ADxE (Etoposide

150 mg/m2/d

3 days) Randomisation 2: Arm A: long maintenance therapy, 1 year [6-Thioguanin 40 mg/ m2

daily HD_Cytarabine 1g/m2

infusion, day: 1-3, 6x Cytarabine, 20-40mg/m2, i.th.

day: 1 Cytarabine, Methotraxate, Prednisolone i.th.

day1

week: 5, 7, 9) Arm B: short maintenance therapy, 8 weeks (6-Thioguanine: 40 mg/ m2

daily

week: 4-8 Cytarabine: 40mg/m2

day: 1-4, each 4 weeks Cytarabine, Methotraxate, Prednisolone i.th.

day: 1, 14, 28, 42) The early treatment response (% blasts before the second treatment block

days 21-28) and treatment response after the second treatment block (% blasts day 42), event-free, disease-free and overall survival and AML toxicity rates will be evaluated.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of an AML (It. WHO classification 2008) 2. Ages 0 to 18 years, either sex 3. Informed Consent of the guardians

Exclusion criteria

Exclusion criteria: 1. Existing illnesses / syndromes which exclude treatment 2. Patients with trisomy 21 and ML-DS and/or transient myeloproliferative syndrome (referred to TMD-prevention study or the ML-DS 2006 study) 3. Refusal of treatment/missing consent to treatment or protocol 4. Pregnancy/breastfeeding 5. Patients of child-bearing age who decline a pregnancy test 6. Previous-therapy with cytostatic medicines of more than 14 days

Design outcomes

Primary

Measure	Time frame
1. Event-Free Survival (EFS) of the randomized patients. The EFS will be calculated from day 0 (date of diagnosis) to the first event (non-response, relapse, second malignancy or death for any reason) or the last follow-up. 2. Disease-Free Survival (DFS). The DFS will be calculated from date of randomization to the first event (relapse, second malignancy or death for any reason) or the last follow-up.	—

Measure

Time frame

1. Event-Free Survival (EFS) of the randomized patients. The EFS will be calculated from day 0 (date of diagnosis) to the first event (non-response, relapse, second malignancy or death for any reason) or the last follow-up. 2. Disease-Free Survival (DFS). The DFS will be calculated from date of randomization to the first event (relapse, second malignancy or death for any reason) or the last follow-up.

—

Secondary

Measure	Time frame
1. Overall survival 2. Detection of molecular relapse 3. Response kinetics for minimal residual disease. The minimal Rest Disease (MRD) will be monitored at the start of each treatment element in the peripheral blood (PB) and bone marrow samples (BM). In all patients with molecular or cytogenetic markers for MDR (Fusion genes AML1/ETO, CBL/MYH11, MLL/X, OTT/MAL; Mutations: NPM1, FLT3-ITD, WT1, c-kit, GATA1, CEPBa, RAS) 4. Relapse incidence 5. Quality of life through toxicity monitoring 6. Assessment of safety: Serious Adverse Events (SAE), long-term follow-up of late adverse effects	—

Measure

Time frame

1. Overall survival 2. Detection of molecular relapse 3. Response kinetics for minimal residual disease. The minimal Rest Disease (MRD) will be monitored at the start of each treatment element in the peripheral blood (PB) and bone marrow samples (BM). In all patients with molecular or cytogenetic markers for MDR (Fusion genes AML1/ETO, CBL/MYH11, MLL/X, OTT/MAL; Mutations: NPM1, FLT3-ITD, WT1, c-kit, GATA1, CEPBa, RAS) 4. Relapse incidence 5. Quality of life through toxicity monitoring 6. Assessment of safety: Serious Adverse Events (SAE), long-term follow-up of late adverse effects

—

Countries

Austria, Czech Republic, Germany, Slovakia, Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026