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
AAML1831 - 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
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Clinical Trial Information
Trial Contact: Parker, Melanie; Spinelli, Jennifer; Dubberly, Paige D; Armatti, Julie M; Doyle, Katherine M
Trial Phone: 321-843-1036 ; 321.841.5357 ; 321-841-7561 ; 321-843-5284 ; 3218412008
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IRB No: AAML1831
Protocol Abbrev: AAML1831
Principal Investigator: Amy A. Smith, MD
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: AAML1831
Treatment: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Asparaginase; Drug: Asparaginase Erwinia chrysanthemi; Behavioral: Cogstate Assessment Battery; Drug: Cytarabine; Drug: Daunorubicin Hydrochloride; Drug: Dexrazoxane Hydrochloride; Drug: Etoposide; Drug: Gemtuzumab Ozogamicin; Drug: Gilteritinib Fumarate; Drug: Liposome-encapsulated Daunorubicin-Cytarabine; Drug: Methotrexate; Drug: Mitoxantrone Hydrochloride; Drug: Therapeutic Hydrocortisone;
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT04293562
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Objective
To compare event-free survival (EFS) in children with de novo acute myeloid leukemia (AML) without FLT3 mutations who are randomly assigned to standard induction therapy on Arm A with daunorubicin, cytarabine (DA) and gemtuzumab ozogamicin (GO) (DA-GO) versus Arm B with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and GO.
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Key Eligibility
Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease; Sexes Eligible for Study: All; Ages up to 22 Years (Child, Adult)
