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NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

Phase 3
18 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event free survival

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Henrik Hasle, MD

Investigator Role:

Study Chair

Investigator Affiliation:

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


Denmark: National Board of Health

Study ID:




Start Date:

January 2004

Completion Date:

January 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • AML
  • Children
  • Gemtuzumab ozogamicin
  • Stem cell transplantation
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid