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    Association details:
    Biomarker:PML-RARA fusion
    Cancer:Acute Promyelocytic Leukemia
    Drug:arsenic trioxide (Apoptosis stimulant)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    10/20/2020
    Excerpt:
    TRISENOX is an arsenical indicated:...In combination with tretinoin for treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
    Secondary therapy:
    tretinoin
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    10/20/2020
    Excerpt:
    TRISENOX is an arsenical indicated...For induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrialsregister.eu
    Title:

    Arsenical combined with all-trans retinoic acid for acute promyelocytic leukemia: a multicenter randomized controlled trial

    Excerpt:
    ...Rate of Event-free survival (EFS) - Rate of Event-free survival (EFS); Rate of hematological complete remission - Rate of hematological complete remission; Overall survival rate - Overall survival rate; Rate of incidence of relapse - Rate of incidence of relapse; Incidence of hematological and non-hematological toxicity episodes during treatment - Incidence of hematological and non-hematological toxicity episodes during treatment; Quality of life at the end of induction therapy and at the end of the consolidation course - Quality of life at the end of induction therapy and at the end of the consolidation course; PML/RARa fusion transcripts - PML/RARa fusion transcripts...
    Trial ID:
    ChiCTR-IPR-15006821
    Evidence Level:
    Sensitive: C2 – Inclusion Criteria
    New
    Source:
    clinicaltrials.gov
    Title:

    Phase III Trial in Acute Promyelocytic Leukemia Patients

    Excerpt:
    ...- Serum creatinine ≤ 3.0 mg/dL (≤ 260 µmol/L) The confirmation of diagnosis at genetic level (microspeckled PML nuclear distribution by PGM3 monoclonal antibody and/or PML/RARa fusion by RT-PCR and/or demonstration of t(15;17) by karyotyping) will be mandatory for patient eligibility....
    Trial ID:
    APL0406