Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed Low-to-intermediate Risk Acute Promyelocytic Leukemia

  • End date
    Dec 26, 2024
  • participants needed
  • sponsor
    Gruppo Italiano Malattie EMatologiche dell'Adulto
Updated on 26 January 2021
acute promyelocytic leukemia
white blood cells


The therapeutic advantage of the association of ATRA + Arsenic Trioxide is more favorable and manageable as compared to ATRA + chemotherapy. Nevertheless, at present, there is not enough information on the incidence of long-term side effects.

This study, as well as other similar studies conducted around Europe, will focus on following patients treated with this therapy on a long-term basis.

Once all studies in Europe will be concluded, all data will be analyzed together.


Considering the clear therapeutic advantage associated with ATRA+ATO combination therapy and the more favorable and overall manageable safety profile compared to ATRA+chemotherapy, the benefits of the combination in the first-line indication do appear to overweigh the risks.

However, no information regarding the actual adverse event (AE) incidence and the long-term toxicity of ATRA+ATO is available at present and therefore, as a postmarketing commitment, TEVA (the Company holding the Marketing Authorisation of Trisenox (Arsenic trioxide)) is setting up a long-term safety cohort study of Trisenox in newly diagnosed low- to intermediate-risk APL patients retrospectively analyzing data from APL disease registries all around Europe.

As a result, this observational study is part of the retrospective PASS Study (A Post-Authorisation Long-Term Retrospective Safety Cohort Study of Arsenic Trioxide in First Line Low-to Intermediate-Risk Acute Promyelocytic Leukaemia Patients) that will use data from multinational APL disease registries in Europe. The present study will focus on Italian patients.

Condition Acute myeloid leukemia, Acute Promyelocytic Leukemia, Acute Myelogenous Leukemia (AML)
Treatment Arsenic trioxide
Clinical Study IdentifierNCT03751917
SponsorGruppo Italiano Malattie EMatologiche dell'Adulto
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

APL diagnosis based on cytological criteria and confirmed by the presence of the (15;17) translocation and/or the presence of the PML/RARA rearrangement (with the determination of the breakpoint subtype)
Newly diagnosed low- to intermediate-risk APL (white blood cells [WBC] count 10x103/L)
First line treatment with ATRA+ATO
Aged 18 years or above
Signed informed consent, if applicable

Exclusion Criteria

High risk APL (WBC count > 10x103/L)
APL relapse
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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