Condition: Acute Myeloid Leukemia · Sponsor: Children's Oncology Group
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia 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. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) 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, 2) to study the effects, good and/or b…
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Children's Hospital of Alabama | Birmingham, Alabama, United States | Recruiting |
| USA Health Strada Patient Care Center | Mobile, Alabama, United States | Recruiting |
| Banner Children's at Desert | Mesa, Arizona, United States | Recruiting |
| Phoenix Childrens Hospital | Phoenix, Arizona, United States | Recruiting |
| Banner University Medical Center - Tucson | Tucson, Arizona, United States | Recruiting |
| Arkansas Children's Hospital | Little Rock, Arkansas, United States | Recruiting |
| Kaiser Permanente Downey Medical Center | Downey, California, United States | Recruiting |
| City of Hope Comprehensive Cancer Center | Duarte, California, United States | Recruiting |
| Loma Linda University Medical Center | Loma Linda, California, United States | Recruiting |
| Miller Children's and Women's Hospital Long Beach | Long Beach, California, United States | Recruiting |
| Children's Hospital Los Angeles | Los Angeles, California, United States | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
+ 193 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04293562