Trial Details 144 Total Sites

A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations

This phase III trial compares standard chemotherapy to therapy with 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 bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.

New York City, New York
facility
NYP/Weill Cornell Medical Center
facility
Mount Sinai Hospital
+2 more facilities
4 facilities
Recruiting
Los Angeles, California
facility
Mattel Children's Hospital UCLA
facility
Children's Hospital Los Angeles
+1 more facilities
3 facilities
Recruiting
Chicago, Illinois
facility
University of Illinois
facility
Lurie Children's Hospital-Chicago
2 facilities
Recruiting
Brooklyn, New York
facility
Maimonides Medical Center
1 facility
Recruiting
Houston, Texas
facility
M D Anderson Cancer Center
facility
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
2 facilities
Recruiting
Philadelphia, Pennsylvania
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Saint Christopher's Hospital for Children
facility
Children's Hospital of Philadelphia
2 facilities
Recruiting
Phoenix, Arizona
facility
Phoenix Childrens Hospital
1 facility
Recruiting
San Antonio, Texas
facility
Methodist Children's Hospital of South Texas
facility
Children's Hospital of San Antonio
+1 more facilities
3 facilities
Recruiting
San Diego, California
facility
Rady Children's Hospital - San Diego
1 facility
Recruiting
Dallas, Texas
facility
UT Southwestern/Simmons Cancer Center-Dallas
facility
Medical City Dallas Hospital
2 facilities
Recruiting
Austin, Texas
facility
Dell Children's Medical Center of Central Texas
1 facility
Recruiting
Jacksonville, Florida
facility
Nemours Children's Clinic-Jacksonville
1 facility
Recruiting