Studies Open for Enrollment

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

The primary goal of this 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.

Candidates
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

Requirements
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

How to Participate
To get started, please contact:
Rakesh Goyal, MD
412-692-5055

Additional Resources
Leukemia
Down Syndrome
Study Description at National Institutes of Health

Principal Investigator
Rakesh Goyal, MD
Pediatric Hematology/Oncology

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