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Compares treatment options 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
ClinicalTrials.gov ID: NCT04293562
What this study is testing
What is Asparaginase Erwinia chrysanthemi?
Asparaginase Erwinia chrysanthemi is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Asparaginase Erwinia chrysanthemi (Recombinant)-rywn, Asparaginase Erwinia chrysanthemi, Recombinant-rywn.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- 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...
- Patient must have 1 of the following:
- \>= 20% bone marrow blasts (obtained within 14 days prior to enrollment)
You likely can't join if
- 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
See the full eligibility 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 [WBC] count \>= 10,000/uL with \>= 10% blasts or a WBC count of \>= 5,000/uL with \>= 20% blasts) circulating leukemic...
- ARM 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 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: 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
- 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
- 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 consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
- 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 enrollment, defined as ejection fraction (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...
- 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
- ARM D: Patient does not have any congenital long QT syndrome or congenital heart block
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Downey, California, United States
- Duarte, California, United States
- Loma Linda, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Madera, California, United States
- Oakland, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Aurora, Colorado, United States
+ 144 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States and 158 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.