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A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

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Trial Profile

A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2022

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At a glance

  • Drugs Gemtuzumab ozogamicin (Primary) ; Asparaginase; Cytarabine; Cytarabine; Daunorubicin; Etoposide; Mitoxantrone
  • Indications Acute myeloid leukaemia
  • Focus Registrational; Therapeutic Use

    • Most Recent Events

    • 18 Mar 2022 Genomic data of patients from two studies (AAML03P1 and AAAML0531 trials) were used to assess the pharmacogenomic impact of SNPs in DNA damage response (DDR) pathway genes on response to GO treatment, presented at the 123rd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
    • 06 Jan 2022 Results of data from the AML02 (n=166) and COG-AAM05L31 (n=931) trials, assessing comprehensive pharmacogenomic evaluation of ara-C pathway and develop a polygenic score predictive of treatment outcome that also holds clinical utility for designing chemotherapeutic treatment regimens, published in the Journal of Clinical Oncology
    • 14 Dec 2021 Results assessing the pharmacogenomic impact of SNPs in DNA damage response (DDR) pathway genes on GO treatment response. We genotyped 132 SNPs in 42 genes involved in DNA damage repair pathway in DNA samples from 470 patients treated with standard chemotherapy in AAML0531 trial (ADE arm) and 755 patients treated with addition of GO to standard therapy in AAML03P1 and AAAML0531 trials (ADE+GO arm), presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
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