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NCT Number: NCT00476541

NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Pediatrics, Aarhus University Hospital Skejby, Aarhus, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AML as defined by the diagnostic criteria,
  • Age < 19 years at time of study entry,
  • Written informed consent

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

Treatment and study plan

Gemtuzumab Ozogamicin

Drug

Two courses of Gemtuzumab vs. no further therapy

Other names: Mylotarg

Primary outcomes

  1. Event free survival

    Time frame: 5 years

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

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Sponsors and collaborators

Lead sponsor

University of Aarhus

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Registry information

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
May 22, 2007
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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