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

Completed · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia Post Cytotoxic Therapy, Recurrent Childhood Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID: NCT02642965
Run by: Children's Oncology Group
People needed: 38
Starts: 2016-05-02
Expected to finish: 2023-06-30
Last updated by the study team: 2023-09-08

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have had histologic verification of AML at original diagnosis
Patient must have one of the following:
Recurrent disease with >= 5% blasts in the bone marrow (M2/M3 bone marrow), with or without extramedullary disease.
Recurrent disease with an absolute blast count greater than 1,000 per microliter in the peripheral blood with or without extramedullary disease
To be eligible for the dose-finding phase: (the dose-finding phase completed in 12/2016)
Relapsed patients
Patients must be in first relapse, and
Patients must not have received prior re-induction therapy
Refractory patients
Patients must not have received more than one attempt at remission induction, which may consist of up to two different therapy courses; Children Oncology Group (COG) AAML1031 de novo therapy including induction I and induction II is an example
Treatment-related AML (t-AML)
Patients must be previously untreated for secondary AML
To be eligible for the phase 2 efficacy phase:
Relapse patients:
Patients must be in first marrow relapse, and
Patients must not have received prior re-induction therapy; donor lymphocyte infusion (DLI) is considered a re-induction attempt
Patients must have the status of CNS1 or CNS2 only, and no clinical signs or neurologic symptoms suggestive of CNS leukemia, such as cranial palsy
Patients must have a performance status corresponding to an Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; Note: patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, stem cell transplant or radiotherapy prior to entering this study; all prior treatment-related toxicities must have resolved to =< grade 2 prior to enrollment
Myelosuppressive chemotherapy: must not have received myelosuppressive chemotherapy within 3 weeks of entry onto this study (excluding hydroxyurea)
Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of CPX-351
Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent such as steroids, retinoids; Note: for agents that have known adverse events occurring beyond 7 days after administration (i.e. monoclonal antibodies), this period must be extended beyond the time during which acute adverse events are known to occur
Radiation therapy (RT): >= 2 weeks for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation; Note: patients must have received =< than 13.6 Gray (Gy) prior radiation to the mediastinum
Stem cell transplant (SCT): no evidence of active graft vs. host disease for at least 4 weeks; for allogeneic SCT patients, >= 3 months must have elapsed since transplant
Must have received no more than 1 prior autologous or allogeneic stem cell transplant.

You may not qualify if…

Patients who have received > 450 mg/m\^2 daunorubicin equivalents; patients who relapse after receiving AAML0531/AAML1031 therapy will be eligible for this study, provided they have not received any additional anthracyclines; NOTE: for the purposes of determining eligibility for this protocol, the following cardiotoxicity multipliers will be used to determine daunorubicin equivalents:
Doxorubicin (doxorubicin hydrochloride): 1
Mitoxantrone: 3
Idarubicin: 3
Epirubicin: 0.5
Patients who are currently receiving another investigational drug
Patients receiving medications for treatment of left ventricular systolic dysfunction
Patients with any of the following diagnoses:
Acute promyelocytic leukemia (APL)
Down syndrome
Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
Wilson's disease and any other disorder of copper metabolism
Juvenile myelomonocytic leukemia (JMML)
Patients with documented active, uncontrolled infection at the time of study entry
Patients with known active hepatitis B virus (HBV) and hepatitis C virus (HCV) infections
Patients with prior allergy to daunorubicin and/or cytarabine
Female patients who are pregnant are ineligible
Lactating females are not eligible
Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 6 months after the last dose of chemotherapy

Where it is running

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
Riley Hospital for Children — Indianapolis, Indiana, United States
Ascension Saint Vincent Indianapolis Hospital — Indianapolis, Indiana, United States
University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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