Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years (AML2012)

Vastra Gotaland Region

Status and phase: Unknown; Phase 3

Conditions: Pediatric Acute Myeloblastic Leukemia

Treatments: Drug: Randomisation course 2 ADxE versus FLADx; Drug: Randomisation course 1 mitoxantrone versus DaunoXome

Study type: Interventional

Funder types: Other

Identifiers

NCT01828489

NOPHO-DBH-AML2012

2012-002934-35 (EudraCT Number)

Details and patient eligibility

About

This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).

Enrollment: 300 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. AML as defined by the WHO diagnostic criteria
2. Age < 19 years at time of diagnosis
3. Written informed consent

Exclusion criteria

1. Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
2. AML secondary to previous bone marrow failure syndrome.
3. Down syndrome (DS)
4. Acute promyelocytic leukaemia (APL)
5. Myelodysplastic syndrome (MDS)
6. Juvenile Myelomonocytic Leukaemia (JMML)
7. Known intolerance to any of the chemotherapeutic drugs in the protocol.
8. Fanconi anaemia
9. Major organ failure precluding administration of planned chemotherapy.
10. Positive pregnancy test
11. Lactating female or female of childbearing potential not using adequate contraception

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Standard arm MEC and ADxE

Active Comparator group

Description:

Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two

Treatment:

Drug: Randomisation course 2 ADxE versus FLADx

Drug: Randomisation course 1 mitoxantrone versus DaunoXome

Experimental DxEC and standard ADxE

Experimental group

Description:

Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two

Treatment:

Drug: Randomisation course 1 mitoxantrone versus DaunoXome

Standard arm MEC and experimental FLADx

Experimental group

Description:

Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two

Treatment:

Drug: Randomisation course 2 ADxE versus FLADx

Experimental DxEC and experimental FLADx

Experimental group

Description:

Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two

Treatment:

Drug: Randomisation course 2 ADxE versus FLADx

Drug: Randomisation course 1 mitoxantrone versus DaunoXome