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    Association details:
    Biomarker:NPM1 mutation
    Cancer:Acute Myelogenous Leukemia
    Drug:Mylotarg (gemtuzumab ozogamicin) (DNA replication inhibitor, CD33-targeted antibody-drug conjugate)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    06/14/2022
    Excerpt:
    Acute Myeloid Leukemia (Age ≥18 years)...Gemtuzumab ozogamicin may be beneficial in NPM1-mutated AML...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Blood
    Title:

    Impact of gemtuzumab ozogamicin on MRD and relapse risk in NPM1 mutated AML patients: results from the AMLSG 09-09 Trial

    Published date:
    08/18/2020
    Excerpt:
    We determined NPM1mut transcript levels (TL) by RQ-PCR and evaluated the prognostic impact of NPM1mut MRD and the effect of gemtuzumab ozogamicin (GO) on NPM1mut TL and the cumulative incidence of relapse (CIR) in patients with NPM1mut AML enrolled in the randomized phase III AMLSG 09-09 trial. The addition of GO to intensive chemotherapy in NPM1mut AML resulted in a significantly better reduction of NPM1mut TL across all treatment cycles leading to a significantly lower relapse rate.
    Secondary therapy:
    Chemotherapy
    DOI:
    10.1182/blood.2020005998
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Study of Chemotherapy in Combination With All-trans Retinoic Acid (ATRA) With or Without Gemtuzumab Ozogamicin in Patients With Acute Myeloid Leukemia (AML) and Mutant Nucleophosmin-1 (NPM1) Gene Mutation

    Excerpt:
    ...- Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories....
    Trial ID:
    AMLSG 09-09
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Phase III study of chemotherapy in combination with ATRA with or without gemtuzumab ozogamicin in patients with acute myeloid leukemia and NPM1 gene mutation Phase III Studie zu Chemotherapie in Kombination mit All-Trans Retinsäure (ATRA) mit oder ohne Gemtuzumab Ozogamicin bei Patienten mit Akuter Myeloischer Leukämie (AML) und Mutation im Nucleophosmin 1 (NPM1) Gen

    Excerpt:
    ...Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study • Patients with confirmed diagnosis of acute myeloid leukemia according to the World Health Organization (WHO) classification • Presence of NPM1 mutation as assessed in one of the central AMLSG reference laboratories. ...
    Trial ID:
    2009-011889-28
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    EHA 2023
    Title:

    FLAG-IDA COMBINED WITH GEMTUZUMAB OZOGAMICIN (GO) REDUCED MRD LEVELS AND IMPROVED OVERALL SURVIVAL IN NPM1MUT AML INDEPENDENT OF FLT3 AND MRD STATUS, RESULTS FROM THE AML19 TRIAL

    Published date:
    05/11/2023
    Excerpt:
    To analyse the impact of FLAG-Ida-GO on MRD and outcome of post-induction therapy in NPM1mut AML with and without a FLT3 mutation...FLAG-Ida-GO improved the OS of patients with NPM1mut AML and reduced the number who were PB PC2MRD+ve compared to DA-GO.
    Secondary therapy:
    FLAG-IDA