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

Last updated: December 31, 2021
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Treatment

N/A

Clinical Study ID

NCT03751917
APL0618
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 thedetermination of the breakpoint subtype).
  • Newly diagnosed low- to intermediate-risk APL (white blood cells [WBC] count ≤10x103/µL)
  • First line treatment with ATRA+ATO
  • Aged 18 years or above
  • Signed informed consent, if applicable

Exclusion

Exclusion Criteria:

  • High risk APL (WBC count > 10x103/µL)
  • APL relapse

Study Design

Total Participants: 100
Study Start date:
April 14, 2020
Estimated Completion Date:
December 31, 2024

Study Description

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.

Connect with a study center

  • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia

    Alessandria,
    Italy

    Active - Recruiting

  • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto

    Bari,
    Italy

    Active - Recruiting

  • UO Ematologia con trapianto-Universita' degli Studi di Bari Aldo Moro

    Bari,
    Italy

    Site Not Available

  • Azienda Ospedaliera - Papa Giovanni XXIII

    Bergamo,
    Italy

    Site Not Available

  • Asst Degli Spedali Civili Di Brescia - Uo Ematologia

    Brescia,
    Italy

    Active - Recruiting

  • Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo

    Cagliari,
    Italy

    Active - Recruiting

  • CTMO - Ematologia - Ospedale "Binaghi"

    Cagliari,
    Italy

    Site Not Available

  • U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo

    Castelfranco Veneto,
    Italy

    Active - Recruiting

  • A.O. Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - U.O. di Ematologia

    Catanzaro,
    Italy

    Site Not Available

  • Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti

    Genova,
    Italy

    Active - Recruiting

  • U.O.C. di Ematologia 1 e 2 IRCCS AOU San Martino-IST

    Genova,
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico UOC Oncoematologia

    Milano,
    Italy

    Site Not Available

  • Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia

    Milano,
    Italy

    Active - Recruiting

  • Ospedale Niguarda " Ca Granda" - SC Ematologia

    Milano,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera "S.Gerardo"

    Monza,
    Italy

    Site Not Available

  • Napoli Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

    Naples,
    Italy

    Active - Recruiting

  • Ospedali Riuniti "Villa Sofia-Cervello"

    Palermo,
    Italy

    Active - Recruiting

  • U.O. Ematologia Clinica - Azienda USL di Pescara

    Pescara,
    Italy

    Site Not Available

  • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali

    Roma,
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica

    Roma,
    Italy

    Active - Recruiting

  • Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia

    Roma,
    Italy

    Site Not Available

  • Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli

    Roma,
    Italy

    Site Not Available

  • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia

    Roma,
    Italy

    Active - Recruiting

  • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia

    San Giovanni Rotondo,
    Italy

    Active - Recruiting

  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2

    Torino,
    Italy

    Active - Recruiting

  • Dipartimento di Oncologia Ematologia 2 A.O. Citta' della Salute S. G. Battista

    Torino,
    Italy

    Site Not Available

  • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia

    Vicenza,
    Italy

    Active - Recruiting

  • ULSS N.6 Osp. S. Bortolo

    Vicenza,
    Italy

    Site Not Available

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