Trial Information

Summary: COG #AAML0531: Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents and Young Adults

You have/your child has been asked to participate in this research study because you have/your child has been diagnosed with Acute Myeloid Leukemia (AML).  The purposes of this research study are:

1.             To see if adding Mylotarg (gemtuzumab) to the current standard AML treatment will improve the cure rate without causing more serious side effects

2.             To compare the outcome of children who have higher risk disease and receive a stem cell transplant (SCT) to children who do not have higher risk disease and do not receive SCT.

3.             To evaluate how well children with Down syndrome (who are over 4 years old) do when they receive the standard chemotherapy without gemtuzumab

4.             To do laboratory studies on biological specimens to improve understanding of AML biology. 

The expected length of you/your child’s treatment on this research study for 6 to 8 months.  After your/your child’s treatment on this study is over, your/your child’s medical condition will be followed with routine examinations.  We will continue to collect medical information about once a year for 10 years from the time you/your child begin participation in the study.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: December 1, 2008 at 3:15:45 PM