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

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

Trial Details

NCT ID
NCT04293562
Phase
PHASE3
Sponsor
Children's Oncology Group
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Asparaginase Erwinia chrysanthemi
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Mesa, Arizona, United States|33.42227,-111.82264
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Downey, California, United States|33.94001,-118.13257
  • Oakland, California, United States|37.80437,-122.2708

Key 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 extramedullar…
  • Patient must have 1 of the following:

For full eligibility, visit ClinicalTrials.gov.

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