A Phase 1/2 Study of CPX-351 (NSC# 775341) Alone Followed by Fludarabine, Cytarabine, and G-CSF (FLAG) for Children With Relapsed Acute Myeloid Leukemia (AML)

This phase I/II trial studies the side effects and best dose of liposome-encapsulated
daunorubicin-cytarabine when given with fludarabine phosphate, cytarabine, and filgrastim and
to see how well they work in treating younger patients with acute myeloid leukemia that has
come back after treatment (relapsed) or is not responding to treatment (is refractory).
Liposome-encapsulated daunorubicin-cytarabine is made up of two chemotherapy drugs,
cytarabine and daunorubicin hydrochloride, and works to stop cancer cell growth by blocking
the cells from dividing. Drugs used in chemotherapy, such as fludarabine phosphate and
cytarabine, 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. Filgrastim may
increase the production of blood cells and may help the immune system recover from the side
effects of chemotherapy. Giving liposome-encapsulated daunorubicin-cytarabine followed by
fludarabine phosphate, cytarabine, and filgrastim may be a better treatment for patients with
relapsed acute myeloid leukemia and may cause fewer side effects to the heart, a common
effect of other chemotherapy treatments for acute myeloid leukemia.