PLEU20095 / AAML1831 / Mullen
Research Question:
Compares standard chemotherapy to therapy with CPX-351 and/or gilteritinib for patients
with newly diagnosed acute myeloid leukemia with or without FLT3 mutations.
Basic Study Information
Purpose:
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 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.
Location: University of Rochester Medical Center
Study Reference #: PLEU20095
Lead Researcher (Principal Investigator)
Lead Researcher:
Craig Mullen
Study Contact Information
Study Contact: Clinical Trials Office
Study Location: Wilmot Cancer Institute, University of Rochester Medical Center
Study Email: WCICTOResearch@urmc.rochester.edu
Additional Study Details
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