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    Association details:
    Biomarker:TP53 mutation
    Cancer:Acute Myelogenous Leukemia
    Drug:decitabine (DNMT inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine in Patients With Acute Myeloid Leukemia

    Excerpt:
    ...- Eligible patient must show evidence of wild-type (WT) p53 as assessed by DNA sequencing; note, that since patients with AML have a rapidly proliferating disease, patient can be enrolled and begin treatment prior to obtaining the results of this test; patients who are found to the TP53 mutated will be removed from study and can continue on single agent decitabine; however patients will continue to be followed for toxicity...
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Source:
    clinicaltrials.gov
    Title:

    Single Agent Decitabine in TP53 Mutated Relapsed/Refractory Acute Myeloid Leukemia

    Excerpt:
    ...- TP53 mutant AML....
    Trial ID:
    NCT03063203
    More C2 evidence
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    Go to data
    Source:
    clinicaltrials.gov
    Title:

    Genomic Predictors of Decitabine Response in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

    Excerpt:
    ...- Somatic TP53 mutation...
    Trial ID:
    NCT01687400
    Less C2 evidence
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Hematology
    Title:

    Outcomes of newly diagnosed acute myeloid leukemia with myelodysplasia related changes and elderly acute myeloid leukemia following decitabine therapy in combination with priming regimen

    Published date:
    09/23/2021
    Excerpt:
    Totally 69 newly diagnosed AML-MRC and elderly AML treated with decitabine and priming regimen were enrolled….There were 39 and 10 cases achieving complete remission (CR) and partial remission (PR), respectively, with CR rate of 56.5% and overall response (OR) rate of 71%....TP53 mutation and platelets not doubling after treatment were independent prognostic factors affecting overall survival...the multivariate analysis showed that only TP53 mutation and doubling of platelets after treatment had significant impacts on OS (Table 6).
    Secondary therapy:
    Chemotherapy
    DOI:
    10.1080/16078454.2021.1975947
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    Cancer
    Title:

    Outcomes of TP53-mutant acute myeloid leukemia with decitabine and venetoclax

    Published date:
    07/13/2021
    Excerpt:
    Outcomes were significantly worse in patients who had TP53mut AML compared with those who had wild-type TP53 AML, with an overall response rate of 66% vs 89% (P = .002), a complete response/complete response with incomplete hematologic recovery rate of 57% vs 77% (P = .029), and a 60-day mortality of 26% vs 4% (P < .001), respectively....Patients with TP53mut AML have lower response rates and shorter survival with DEC10-VEN.
    DOI:
    https://doi.org/10.1002/cncr.33689
    Trial ID:
    DEC10-VEN
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    N Engl J Med
    Title:

    TP53 and Decitabine in Acute Myeloid Leukemia and Myelodysplastic Syndromes

    Excerpt:
    Response rates were higher among patients with an unfavorable-risk cytogenetic profile than among patients with an intermediate-risk or favorable-risk cytogenetic profile (29 of 43 patients [67%] vs. 24 of 71 patients [34%], P<0.001) and among patients with TP53 mutations than among patients with wild-type TP53 (21 of 21 [100%] vs. 32 of 78 [41%], P<0.001)....Patients with AML and MDS who had cytogenetic abnormalities associated with unfavorable risk, TP53 mutations, or both had favorable clinical responses and robust (but incomplete) mutation clearance after receiving serial 10-day courses of decitabine.
    DOI:
    10.1056/NEJMoa1605949
    Trial ID:
    NCT01687400