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

Acute Promyelocytic Leukemia Clinical Trial

— APL0618  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03751917
• Other study ID #: APL0618
• Status: Recruiting
• Start date: April 14, 2020
• Est. completion date: December 2024

Study information

• Verified date: December 2021
• Source: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Contact: Paola Fazi
• Phone: +39 0670390514
• Email: p.fazi[@]gimema.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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/µL)
• First line treatment with ATRA+ATO
• Aged 18 years or above
• Signed informed consent, if applicable

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Promyelocytic Leukemia
• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

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.

Locations

Country	Name	City	State
Italy	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	Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia	Roma
Italy	Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia	Roma
Italy	Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli	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

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of grade III/IV (Common Terminology Criteria for Adverse Events (CTCAE) v4.03) adverse events of special interest (AESI).	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).	At a maximum of 5 years from study entry
Secondary	Number of unexpected serious adverse events (SAEs).	Including grading and relationship as documented in the study.	At a maximum of 5 years from study entry
Secondary	Number of patients developing secondary malignancies.		At a maximum of 5 years from study entry
Secondary	Number of patients developing therapy-related myelodysplastic syndrome (tMDS).		At a maximum of 5 years from study entry
Secondary	Number of patients developing acute myeloid leukemia (tAML).		At a maximum of 5 years from study entry
Secondary	Number of patients who die.		At a maximum of 5 years from study entry

External Links

•   GIMEMA Foundation website