COG AAML1831

Clinical Trial Title 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
Trial Status Open to Enrollment
Start Date 07/21/2020
Location Randall Children's Hospital at Legacy Emanuel
Trial Type Pediatric Cancer (Oncology)
Specific Condition Acute Myeloid Leukemia
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.
Eligibility Criteria

Eligible Patients

  • 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)

      • < 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 cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)

Please contact Legacy's Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | NCT04293562 | 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
Principal Investigator Jason Glover, MD
Contact Name Cancer and Blood Disorders at Randall Children's Hospital at Legacy Emanuel
Contact Phone 503-276-9300
Contact Fax 503-276-9351
Contact E-Mail childcanc@LHS.ORG