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

  • Clinical Trial Information

    Trial Contact: Parker, Melanie; Spinelli, Jennifer; Dubberly, Paige D; Armatti, Julie M; Doyle, Katherine M

  • 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 ID: NCT04293562

  • 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.

  • 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)