NCTN: 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) (AAML1421)

Study ID: AAML1421

NCT Number: NCT02642965

Children's Oncology Group (COG)

Submitted in collaboration with the NCTN/NCORP Data Archive

Trial Title: NCTN: 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) (AAML1421)

Trial Description: 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.

Clinical data presented in the following publication(s):

• PMID 32401633

Disease type(s): Hematopoietic Neoplasm/Leukemia - Acute Myeloid Leukemia

Clinical Dataset(s) included:

• NCT02642965-D1 (PMID 32401633): There is 1 dataset for AAML1421's primary publication, PMID 32401633. The NCT02642965-D1 dataset is a patient level dataset (single row per patient) containing patient characteristics, cytogenetic categories, tumor response, survival, neutrophil count recovery, toxicity, residual disease status, and pharmacokinetic data for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML1421 clinical trial.

You are encouraged to view the PDF data dictionaries found in the "Documents" tab of the dbGaP study page, which may contain additional information regarding the data or the associated publication(s).

• Type: Interventional
• Archive: The database of Genotypes and Phenotypes (dbGaP)