Clinical trialNCT02642965CompletedPhase 1,PHASE2Interventional

Liposome-encapsulated Daunorubicin-Cytarabine, Fludarabine Phosphate, Cytarabine, and Filgrastim in Treating Younger Patients With Relapsed or Refractory Acute Myeloid Leukemia

SponsorChildren's Oncology GroupEnrollment38Acute Myeloid Leukemia Post Cytotoxic TherapyRecurrent Childhood Acute Myeloid LeukemiaSecondary Acute Myeloid Leukemia

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Todd M Cooper
Children's Oncology Group
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

73 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Cancercare Manitoba
Winnipeg, Manitoba, Canada
Iwk Health Centre
Halifax, Nova Scotia, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada
the Montreal Children'S Hospital of the Muhc
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Canada

United States

Children'S Hospital of Alabama
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center
Downey, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children'S Hospital Los Angeles
Los Angeles, California, United States
Valley Children'S Hospital
Madera, California, United States
Ucsf Benioff Children'S Hospital Oakland
Oakland, California, United States
Children'S Hospital of Orange County
Orange, California, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
Ucsf Medical Center-Mission Bay
San Francisco, California, United States
Children'S Hospital Colorado
Aurora, Colorado, United States
Connecticut Children'S Medical Center
Hartford, Connecticut, United States
Alfred I Dupont Hospital for Children
Wilmington, Delaware, United States
Children'S National Medical Center
Washington D.C., District of Columbia, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, United States
Nemours Children'S Clinic-Jacksonville
Jacksonville, Florida, United States
Nemours Children'S Clinic - Pensacola
Pensacola, Florida, United States
Johns Hopkins All Children'S Hospital
St. Petersburg, Florida, United States
Children'S Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Lurie Children'S Hospital-Chicago
Chicago, Illinois, United States
Ascension Saint Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Riley Hospital for Children
Indianapolis, Indiana, United States
University of Kentucky/markey Cancer Center
Lexington, Kentucky, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children'S Cancer Program
Scarborough, Maine, United States
Johns Hopkins University/sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
C S Mott Children'S Hospital
Ann Arbor, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
University of Minnesota/masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States

33 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Cytarabine →Filgrastim →Fludarabine →Cpx-351

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 2 May 2016
Primary completion: 31 Dec 2018
Completion: 30 Jun 2023
Last update posted: 8 Sept 2023
Registered enrollment: 38
Registry id: NCT02642965

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.