PLEU20095 / AAML1831 / Angela Girvin
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 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:
Angela Girvin
Study Contact Information
Study Coordinator: Tina Bowdish
Phone: +1 585-275-9475
Email: tina_bowdish@urmc.rochester.edu
Additional Study Details
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