Spots Global Cancer Trial Database for Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia
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Trial Identification
Brief Title: Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia
Official Title: A Long-Term Retrospective and Prospective Safety Study of Arsenic Trioxide in Patients With Newly Diagnosed, Low- to Intermediate-Risk Acute Promyelocytic Leukemia (APL)
Study ID: NCT03751917
Conditions
Interventions
Study Description
Brief 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.
Detailed 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia, Alessandria, , Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto, Bari, , Italy
UO Ematologia con trapianto-Universita' degli Studi di Bari Aldo Moro, Bari, , Italy
Azienda Ospedaliera - Papa Giovanni XXIII, Bergamo, , Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia, Brescia, , Italy
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo, Cagliari, , Italy
CTMO - Ematologia - Ospedale "Binaghi", Cagliari, , Italy
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo, Castelfranco Veneto, , Italy
A.O. Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - U.O. di Ematologia, Catanzaro, , Italy
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti, Genova, , Italy
U.O.C. di Ematologia 1 e 2 IRCCS AOU San Martino-IST, Genova, , Italy
Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico UOC Oncoematologia, Milano, , Italy
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia, Milano, , Italy
Ospedale Niguarda " Ca Granda" - SC Ematologia, Milano, , Italy
Azienda Ospedaliera "S.Gerardo", Monza, , Italy
Napoli Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli", Naples, , Italy
Ospedali Riuniti "Villa Sofia-Cervello", Palermo, , Italy
U.O. Ematologia Clinica - Azienda USL di Pescara, Pescara, , Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali, Roma, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica, Roma, , Italy
Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia, Roma, , Italy
Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma, , Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia, Roma, , Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia, San Giovanni Rotondo, , Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2, Torino, , Italy
Dipartimento di Oncologia Ematologia 2 A.O. Citta' della Salute S. G. Battista, Torino, , Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia, Vicenza, , Italy
ULSS N.6 Osp. S. Bortolo, Vicenza, , Italy
Contact Details
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