Acute Myeloid Leukemia Treatment Study - Phase III

Gemtuzumab Ozogamicin Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia in Children, Adolescents, and Young Adults

Protocol Description

The primary goal of this Children's Oncology Group study is to increase the cure rate for children/young adults diagnosed with acute myeloid leukemia (AML) or cancer of the bone marrow. Today, about half of children and young adults diagnosed with AML and given standard chemotherapy treatment remain with no signs of cancer for five years. The overall goal of this study is to see if we can increase this cure rate by adding gemtuzumab, a new chemotherapy drug, which goes by the trade name Mylotarg®, without causing more serious side effects. As a multicenter study, about 1,000 participants will be enrolled over three years of which 20 to 30 will be from Children’s Hospital of Pittsburgh of UPMC. A subset of patients with Down syndrome will also be followed through this study.

Eligibility Criteria

Male and female subjects, ranging from 1 month through age 29, will take part in this study over three years. Participants with Down syndrome must be 4 years or older.
Males: 1 month through 29 years
Females: 1 month through 29 years

Among other requirements, participants receive one of two treatment plans, decided by a randomized process. They are assigned to either standard therapy, or the current standard therapy in combination with gemtuzumab. Subjects with Down syndrome enrolled in this study will be automatically assigned to the standard therapy.
Visits: None beyond regular clinical care
Duration: 6 to 8 months

Status: Open for Enrollment

Source of Support
Children’s Oncology Group (Study AAML0531)
National Cancer Institute (NCI)

Additional Resources
Study Description at National Institutes of Health

Primary Investigator(s)

Rakesh Goyal, MD

Contact Information

To get started, please contact:
Rakesh Goyal, MD

Last Update
December 28, 2014
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Last Update
December 28, 2014