Comparing 14 approaches for acute myeloid leukemia
Official title: 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
A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations
- Phase 3
- 14 groups
- Sites in Québec, Calgary and 12 more cities
- Recruiting
Interventions (20)
- Medical procedure
Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic HSCT
- Medication
Asparaginase Erwinia chrysanthemi
Given IM or IV
- Medical procedure
Biospecimen Collection
Undergo blood sample collection
- Medical procedure
Bone Marrow Aspiration
Undergo BM aspiration
- Medical procedure
Bone Marrow Biopsy
BM biopsy
- Medical procedure
Computed Tomography
Undergo CT
- Medication
Cytarabine
Given IV or IT
- Medication
Daunorubicin Hydrochloride
Given IV
- Medication
Dexrazoxane Hydrochloride
Given IV
- Medication
Etoposide
Given IV
- Other intervention
Fludeoxyglucose F-18
Undergo FDG-PET
- Medication
Gemtuzumab Ozogamicin
Given IV
- Medication
Gilteritinib Fumarate
Given PO/NG/G-tube
- Medication
Liposome-encapsulated Daunorubicin-Cytarabine
Given IV
- Medical procedure
Magnetic Resonance Imaging
Undergo MRI
- Medication
Methotrexate
Given IT
- Medication
Mitoxantrone Hydrochloride
Given IV
- Medical procedure
Positron Emission Tomography
Undergo FDG-PET
- Other intervention
Questionnaire Administration
Ancillary studies
- Medication
Therapeutic Hydrocortisone
Given IT
Canadian Sites (15)
15 of 15 recruiting
- Recruiting
Alberta Children's Hospital
Calgary, Alberta
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia
- Recruiting
CancerCare Manitoba
Winnipeg, Manitoba
- Recruiting
IWK Health Centre
Halifax, Nova Scotia
- Recruiting
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario
- Recruiting
Children's Hospital
London, Ontario
- Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario
- Recruiting
Hospital for Sick Children
Toronto, Ontario
- Recruiting
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
Québec
- Recruiting
The Montreal Children's Hospital of the MUHC
Montreal, Quebec
- Recruiting
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec
- Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec
- Recruiting
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for49 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
- +All patients must be enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → on APEC14B1 and consented to EligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → (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 protocolProtocolThe detailed plan a study must follow.Read more → (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 \[WBC\] count \>= 10,000/uL with \>= 10% blasts or a WBC count of \>= 5,000/uL with \>= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)
- +ARMArmOne of the groups in a study, each receiving something different.Read more → C: Patient must be \>= 2 years of age at the time of Late Callback
- +ARM C: Patient must have FLT3/ITD allelic ratio \> 0.1 as reported by Molecular Oncology
- +ARM C: Patient does not have any congenital long QT syndrome or congenital heart block
- +ARM D: Patient must be \>= 2 years of age at the time of Late Callback
- +ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine
- +NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible
- +NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment
- +NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking
- +NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation)
- +NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli
- +All patients and/or their parents or legal guardians must sign a written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
- +ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
- +ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
- +ARM D: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
- +ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
- +ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
Exclusion
- −Fanconi anemia
- −Shwachman Diamond syndrome
- −Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
- −Telomere disorders
- −Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy
- −Any concurrent malignancy
- −Juvenile myelomonocytic leukemia (JMML)
- −Philadelphia chromosome positive AML
- −Mixed phenotype acute leukemia
- −Acute promyelocytic leukemia
- −Acute myeloid leukemia arising from myelodysplasia
- −Therapy-related myeloid neoplasms
- −Patients with persistent cardiac dysfunction prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, defined as ejection fraction (EF) \< 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) \< 24%. \*Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF \>= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen
- −Administration of prior anti-cancer therapy except as outlined below:
- −Hydroxyurea
- −All-trans retinoic acid (ATRA)
- −Corticosteroids (any route)
- −Intrathecal therapy given at diagnosis
- −In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the study treatment
- −ARMArmOne of the groups in a study, each receiving something different.Read more → D: Patient does not have any congenital long QT syndrome or congenital heart block
- −Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
- −Lactating females who plan to breastfeed their infants
- −Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 14 groups in this study.
Group A receives one or more of: Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Daunorubicin Hydrochloride, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Magnetic Resonance Imaging, Methotrexate, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: A: Arm A High Risk Group
Group B receives one or more of: Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Daunorubicin Hydrochloride, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Magnetic Resonance Imaging, Methotrexate, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: B: Arm A Low Risk Group 1
Group C receives one or more of: Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Daunorubicin Hydrochloride, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Magnetic Resonance Imaging, Methotrexate, Mitoxantrone Hydrochloride, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: C: Arm A Low Risk Group 2
Groups D and F receive one or more of: Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Daunorubicin Hydrochloride, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Gilteritinib Fumarate, Magnetic Resonance Imaging, Methotrexate, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: D: Arm AC High Risk Group · F: Arm AD High Risk Group
Groups E and G receive one or more of: Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Daunorubicin Hydrochloride, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Gilteritinib Fumarate, Magnetic Resonance Imaging, Methotrexate, Mitoxantrone Hydrochloride, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: E: Arm AC Low Risk Group 2 · G: Arm AD Low Risk Group 2
Group H receives one or more of: Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Liposome-encapsulated Daunorubicin-Cytarabine, Magnetic Resonance Imaging, Methotrexate, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: H: Arm B High Risk Group
Group I receives one or more of: Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Liposome-encapsulated Daunorubicin-Cytarabine, Magnetic Resonance Imaging, Methotrexate, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: I: Arm B Low Risk Group 1
Group J receives one or more of: Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Liposome-encapsulated Daunorubicin-Cytarabine, Methotrexate, Mitoxantrone Hydrochloride, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: J: Arm B Low Risk Group 2
Groups K and M receive one or more of: Allogeneic Hematopoietic Stem Cell Transplantation, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Gilteritinib Fumarate, Liposome-encapsulated Daunorubicin-Cytarabine, Magnetic Resonance Imaging, Methotrexate, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: K: Arm BC High Risk Group · M: Arm BD High Risk Group
Groups L and N receive one or more of: Asparaginase Erwinia chrysanthemi, Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Computed Tomography, Cytarabine, Dexrazoxane Hydrochloride, Etoposide, Fludeoxyglucose F-18, Gemtuzumab Ozogamicin, Gilteritinib Fumarate, Liposome-encapsulated Daunorubicin-Cytarabine, Magnetic Resonance Imaging, Methotrexate, Mitoxantrone Hydrochloride, Positron Emission Tomography, Questionnaire Administration and Therapeutic Hydrocortisone.
Registry label: L: Arm BC Low Risk Group 2 · N: Arm BD Low Risk Group 2
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a maximum age of 21 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,186 people.
The study is currently expected to finish around June 2029.
The main measurement is taken over: Up to 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Event-free survival (EFS) — measured over Up to 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04293562 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Allogeneic Hematopoietic Stem Cell TransplantationProcedure
Undergo allogeneic HSCT
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Asparaginase Erwinia chrysanthemiDrug
Given IM or IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Biospecimen CollectionProcedure
Undergo blood sample collection
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Bone Marrow AspirationProcedure
Undergo BM aspiration
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Bone Marrow BiopsyProcedure
BM biopsy
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Computed TomographyProcedure
Undergo CT
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About CytarabineDrug
Given IV or IT
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Daunorubicin HydrochlorideDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Dexrazoxane HydrochlorideDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About EtoposideDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Fludeoxyglucose F-18Other
Undergo FDG-PET
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Gemtuzumab OzogamicinDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Gilteritinib FumarateDrug
Given PO/NG/G-tube
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Liposome-encapsulated Daunorubicin-CytarabineDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Magnetic Resonance ImagingProcedure
Undergo MRI
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About MethotrexateDrug
Given IT
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Mitoxantrone HydrochlorideDrug
Given IV
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Positron Emission TomographyProcedure
Undergo FDG-PET
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Questionnaire AdministrationOther
Ancillary studies
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Therapeutic HydrocortisoneDrug
Given IT
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 3 years.
The study as a whole is currently expected to finish around 2029-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,186 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 36 locations, including: Québec, Canada; Calgary, Alberta, Canada; Edmonton, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada, and 30 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and/or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and/or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3/ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and/or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.
Other Sites (29)
C S Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Henry Ford Health Saint John Hospital
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Corewell Health Children's
Royal Oak, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Albany Medical Center
Albany, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
The Steven and Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
NYP/Weill Cornell Medical Center
New York, New York, United States
And 9 more sites worldwide.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.