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Cancer Clinical Trials - COG-AAML1831


Protocol Summary

    Protocol No
    COG-AAML1831
    Principal Investigator
    Michael Burke
    Phase
    III
    Title
    A Phase 3 Randomized Trial for Patients with De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations
    Associated Disease(s)
    Bone Marrow Transplant and Cellular Therapy
    Description (Summary)
    Treatment for AML involves high doses of a common class of chemotherapy drugs called anthracyclines. The anthracycline drugs used in treatment for AML are daunorubicin and mitoxantrone. These drugs are effective at treating AML, but high doses are known to cause long-term side effects, especially to the heart. (Side effects are unintended and unwanted results of treatment.) Study doctors are interested in finding an effective treatment for AML patients that reduces the potential for long-term side effects. This study will compare standard chemotherapy using daunorubicin, cytarabine and gemtuzumab ozogamicin (GO) to chemotherapy using an experimental drug called CPX-351. CPX-351 is made up of daunorubicin and cytarabine. CPX-351 is made in a way that makes the drugs stay in the bone marrow longer and may be more effective. CPX-351 has been shown to be well-tolerated and effective against leukemia in adults and children. It has been given to adults and children with relapsed AML and adults and elderly patients with newly diagnosed AML. CPX-351 (also called Vyxeos®) is approved by the Food and Drug Administration (FDA) for the treatment of adults with newly diagnosed AML related to treatment for another cancer or AML with myelodysplastic features. It is not approved for use in children or young adults with newly diagnosed AML. CPX-351 is made in a way that could be less likely to cause heart problems than traditional anthracycline drugs. Part of this study is to compare effects of all therapy on the heart. All patients on this study will have tests to check your heart function during study treatment and follow-up. Researchers also want to find out the dose and effectiveness of a different investigational drug, called gilteritinib. Some AML patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. The drug gilteritinib has been shown to block the abnormal function of the FLT3 gene that makes cancer cells grow. Gilteritinib is FDA approved for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. It is not yet approved for treatment in children. Results of the FLT3 test will come back during Induction 1. If your AML has high levels of FLT3/ITD or other mutations, your doctor will discuss treatment options with you which may include gilteritinib and you will be offered to participate in a separate arm of this study. You will be asked to sign a separate consent for that treatment. The overall goals of this study are to: • Compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better. In this study, you will get either the CPX-351 or daunorubicin and cytarabine. You will not get both. • To study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations. • To study changes in heart function during and after treatment for AML. Other goals of this study include studying changes in brain function during and after treatment for AML and to understand the biology of AML and treatment.
    Participating Institutions
    Childrens Hospital of Wisconsin
    ClinicalTrials.gov
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Michael Burke, MD

"The steady improvement in survival for children with cancer is a direct result of their enrollment onto clinical trials; without which we would remain decades behind in terms of scientific advances in pediatric cancer." ~Michael J. Burke, MD