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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 1Phase 2
Study Completion Date
2018-12-31
NCT02642965Uploaded 04-15-2023
Access via NCI by Request
PDS UID: nci-data-516
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)
Provider Information
Provider Data DescriptionNCT02642965-D1 Dataset There is 1 dataset associated with PMID 32401633, NCT02642965-D1. The NCT02642965-D1 dataset is a patient level dataset (single row per patient) containing patient characteristics, response, toxicity, and outcome for eligible pediatric acute myeloid leukemia (AML) patients enrolled on the AAML1421 clinical trial.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsAcute Myeloid Leukemia Post Cytotoxic Therapy
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Intervention TypeDrug: Cytarabine
Biological: Filgrastim
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Other: Pharmacological Study
Drug(s)Drug: Cytarabine
Drug: Fludarabine Phosphate
Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Total Enrolled38
RandomizationNa
Blinding MethodNone
Arms InterventionTreatment (CPX-351 and FLAG) - Experimental
Secondary IDNCI-2015-01917
PubMed (PMID)32401633
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Canada
Age Range1 Year to 21 Years (CHILD, ADULT)
Files: NCT02642965-D1
Data DictionaryNCT02642965-D1-Data-Dictionary_2.pdf
DATANCT02642965-D1-Dataset_2.csv
OTHERREADME.pdf
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