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Sunday, November 11, 2007

More Details on Myla’s Study

The clinical trial Myla will participate in is organized by the Children’s Oncology Group (COG). The following content is taken directly from the informed consent form of the study. I've added the hyperlinks.

Project Title: “A Phase III randomized trial of Gemtuzamab Ozogamicin (Mylotarg®) combined with conventional chemotherapy for De Novo Acute Myeloid Leukemia (AML) in children, adolescence, and young adults.”

“AML is a cancer of the bone marrow, the spongy tissue inside the large bones of the body where blood cells are made. In AML, the bone marrow makes large numbers of immature white cells called blasts. These blast cells crowd out the normal cells of the bone marrow. They may flood the bloodstream and invade vital organs such as the brain, testes, ovaries, or skin. These cancerous AML cells can sometimes form a solid tumor called a chloroma.”

“Nearly 500 children are diagnosed with AML every year and half are cured with standard therapy. In other words, half of the children diagnosed with AML and treated as described above remain with no signs of cancer (remission) for five years. The overall goal of this study is to see if we can increase this cure rate without causing more serious side effects of therapy. Side effects are unwanted results of treatment.”

“The standard treatment for this disease is to use a combination of cancer-fighting drugs called chemotherapy. Chemotherapy destroys the leukemia cells in the blood and bone marrow. In the first phase, called Induction 1, we try to remove all the visible signs of leukemia and allow normal blood cells to be restored. This is called remission. The next phase of treatment is called Induction 2. Induction 2 is another round of chemotherapy to kill the few remaining leukemia cells that may have survived Induction 1. In the next phase of treatment, called Intensification 1, more chemotherapy is used to kill any remaining blast cells. Then we do a Stem Cell Transplantation (SCT) or give additional high doses of chemotherapy to try to keep the leukemia from coming back.”

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