NCT04293562 · Children's Oncology Group
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
What this study is about
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations.
View original scientific description
This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and/or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, 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.
Interventions
PROCEDURE
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic HSCT
DRUG
Asparaginase Erwinia chrysanthemi
Given IM or IV
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Bone Marrow Aspiration
Undergo BM aspiration
PROCEDURE
Bone Marrow Biopsy
BM biopsy
PROCEDURE
Computed Tomography
Undergo CT
DRUG
Cytarabine
Given IV or IT
DRUG
Daunorubicin Hydrochloride
Given IV
DRUG
Dexrazoxane Hydrochloride
Given IV
DRUG
Etoposide
Given IV
OTHER
Fludeoxyglucose F-18
Undergo FDG-PET
DRUG
Gemtuzumab Ozogamicin
Given IV
DRUG
Gilteritinib Fumarate
Given PO/NG/G-tube
DRUG
Liposome-encapsulated Daunorubicin-Cytarabine
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
DRUG
Methotrexate
Given IT
DRUG
Mitoxantrone Hydrochloride
Given IV
PROCEDURE
Positron Emission Tomography
Undergo FDG-PET
OTHER
Questionnaire Administration
Ancillary studies
DRUG
Therapeutic Hydrocortisone
Given IT
Primary outcome measures
Event-free survival (EFS)
Time frame: Up to 3 years
The Kaplan-Meier method will be used to estimate 3-year EFS, defined as the time from study entry until induction failure, relapse, secondary malignancy, or death.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831
- Patients must be less than 22 years of age at the time of study enrollment
- Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease
- Patient must have 1 of the following:
- \>= 20% bone marrow blasts (obtained within 14 days prior to enrollment)
- In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy
- \< 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
- A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell \[WB
Where
- Birmingham, Alabama
- Mobile, Alabama
- Mesa, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Downey, California
- Duarte, California
- Loma Linda, California
- Long Beach, California
- Los Angeles, California
- Madera, California
And 133 more locations — see the full list below.
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations