NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

Last updated: May 12, 2016
Sponsor: University of Aarhus
Overall Status: Completed

Phase

3

Condition

Leukemia

Platelet Disorders

Acute Myeloid Leukemia

Treatment

N/A

Clinical Study ID

NCT00476541
NOPHO-AML 2004
  • Ages < 18
  • All Genders

Study Summary

The overall objective is to improve the cure rate of children with newly diagnosed acute myeloid leukemia (AML) who undergo risk-adapted therapy.

Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics and response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) will be evaluated.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • AML as defined by the diagnostic criteria,

  • Age < 19 years at time of study entry,

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Previous chemo- or radiotherapy,

  • AML secondary to previous bone marrow failure syndrome,

  • Down syndrome (DS),

  • Acute promyelocytic leukemia (APL),

  • Juvenile myelomonocytic leukemia (JMML),

  • Myelodysplastic syndrome (MDS),

  • Fanconi anemia,

  • Positive pregnancy test

Study Design

Total Participants: 250
Study Start date:
January 01, 2004
Estimated Completion Date:
January 31, 2012

Study Description

The overall objective is to improve the cure rate of pediatric patients with newly diagnosed acute myeloid leukemia (AML). The specific aims are as follows:

1.1 Therapeutic aims

To improve the event-free survival (EFS) of AML patients who undergo risk-adapted therapy.

To improve the overall survival (OS) by reserving stem cell transplantation (SCT) to high-risk patients based on cytogenetics and response to induction therapy.

To compare the outcome of SCT using HLA-matched sibling donor (MSD) or HLA-matched unrelated donor (MUD).

To assess the efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) as post consolidation therapy.

1.2 Biologic aims

To study minimal residual disease (MRD) levels in blood and bone marrow (BM) at defined time points and to study the prognostic impact of MRD.

To test in vitro cellular drug resistance at diagnosis and relapse, and correlate these data to background factors and clinical outcome.

To secure storage of biological material from diagnosis for future biologic studies

Connect with a study center

  • Department of Pediatrics, Aarhus University Hospital Skejby

    Aarhus, 8200
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

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