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

  • STATUS
    Recruiting
  • End date
    Mar 21, 2023
  • participants needed
    300
  • sponsor
    Vastra Gotaland Region
Updated on 21 January 2021

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).

Details
Condition Pediatric Acute Myeloblastic Leukemia
Treatment Randomisation course 1 mitoxantrone versus DaunoXome, Randomisation course 2 ADxE versus FLADx
Clinical Study IdentifierNCT01828489
SponsorVastra Gotaland Region
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
AML secondary to previous bone marrow failure syndrome
Down syndrome (DS)
Acute promyelocytic leukaemia (APL)
Myelodysplastic syndrome (MDS)
Juvenile Myelomonocytic Leukaemia (JMML)
Known intolerance to any of the chemotherapeutic drugs in the protocol
Fanconi anaemia
Major organ failure precluding administration of planned chemotherapy
Positive pregnancy test
Lactating female or female of childbearing potential not using adequate contraception
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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