APL0618: Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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APL patients The study will be conducted using multinational data from disease registries for APL. The study participants will consist of patients with newly diagnosed, low-to intermediate-risk APL. |
Drug: Arsenic Trioxide
This is an observational study. Patients who have received or are receiving all trans retinoic acid (ATRA) + Arsenic Trioxide will be followed and analyzed.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of grade III/IV (Common Terminology Criteria for Adverse Events (CTCAE) v4.03) adverse events of special interest (AESI). [At a maximum of 5 years from study entry]
AESI are, among others: differentiation syndrome, creatinine, bilirubin, neurotoxicity, aspartate amino transferase/alanine amino transferase (ASAT/ALAT) ratio, haemorrhage, sepsis, QTc prolongation, cardiac events including congestive heart failure (CHF).
Secondary Outcome Measures
- Number of unexpected serious adverse events (SAEs). [At a maximum of 5 years from study entry]
Including grading and relationship as documented in the study.
- Number of patients developing secondary malignancies. [At a maximum of 5 years from study entry]
- Number of patients developing therapy-related myelodysplastic syndrome (tMDS). [At a maximum of 5 years from study entry]
- Number of patients developing acute myeloid leukemia (tAML). [At a maximum of 5 years from study entry]
- Number of patients who die. [At a maximum of 5 years from study entry]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Newly diagnosed low- to intermediate-risk APL (white blood cells [WBC] count ≤10x103/µL)
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First line treatment with ATRA+ATO
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Aged 18 years or above
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Signed informed consent, if applicable
Exclusion Criteria:
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High risk APL (WBC count > 10x103/µL)
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APL relapse
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia | Alessandria | Italy | ||
2 | Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto | Bari | Italy | ||
3 | UO Ematologia con trapianto-Universita' degli Studi di Bari Aldo Moro | Bari | Italy | ||
4 | Azienda Ospedaliera - Papa Giovanni XXIII | Bergamo | Italy | ||
5 | Asst Degli Spedali Civili Di Brescia - Uo Ematologia | Brescia | Italy | ||
6 | Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo | Cagliari | Italy | ||
7 | CTMO - Ematologia - Ospedale "Binaghi" | Cagliari | Italy | ||
8 | U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo | Castelfranco Veneto | Italy | ||
9 | A.O. Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - U.O. di Ematologia | Catanzaro | Italy | ||
10 | Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti | Genova | Italy | ||
11 | U.O.C. di Ematologia 1 e 2 IRCCS AOU San Martino-IST | Genova | Italy | ||
12 | Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico UOC Oncoematologia | Milano | Italy | ||
13 | Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia | Milano | Italy | ||
14 | Ospedale Niguarda " Ca Granda" - SC Ematologia | Milano | Italy | ||
15 | Azienda Ospedaliera "S.Gerardo" | Monza | Italy | ||
16 | Napoli Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" | Naples | Italy | ||
17 | Ospedali Riuniti "Villa Sofia-Cervello" | Palermo | Italy | ||
18 | U.O. Ematologia Clinica - Azienda USL di Pescara | Pescara | Italy | ||
19 | Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali | Roma | Italy | ||
20 | Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica | Roma | Italy | ||
21 | Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia | Roma | Italy | ||
22 | Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli | Roma | Italy | ||
23 | Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia | Roma | Italy | ||
24 | Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia | San Giovanni Rotondo | Italy | ||
25 | Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2 | Torino | Italy | ||
26 | Dipartimento di Oncologia Ematologia 2 A.O. Citta' della Salute S. G. Battista | Torino | Italy | ||
27 | Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia | Vicenza | Italy | ||
28 | ULSS N.6 Osp. S. Bortolo | Vicenza | Italy |
Sponsors and Collaborators
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- APL0618