NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Gemtuzumab

Criteria

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