Overview

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

Status:
Recruiting

Trial end date:
2023-03-01

Target enrollment:
0

Participant gender:
All

Summary

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Vastra Gotaland Region

Treatments:

Daunorubicin
Mitoxantrone

Criteria

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