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

Recruiting

• Conditions: Acute Promyelocytic Leukemia
• Interventions: Drug: Arsenic Trioxide

• Registration Number: NCT03751917
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.
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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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Study Start: 2020-04-14
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-31
• Last Update Posted: 2022-01-04
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
APL patients	Arsenic Trioxide	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 acute myeloid leukemia (tAML).	At a maximum of 5 years from study entry
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 who die.	At a maximum of 5 years from study entry

Trial Locations

Locations (28)

U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo; 🇮🇹 Castelfranco Veneto, Italy

Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico UOC Oncoematologia; 🇮🇹 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

Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2; 🇮🇹 Torino, Italy

Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia; 🇮🇹 Roma, 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

Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto; 🇮🇹 Bari, Italy

A.O. Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - U.O. di Ematologia; 🇮🇹 Catanzaro, Italy

Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali; 🇮🇹 Roma, Italy

Azienda Ospedaliera - Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy

U.O.C. di Ematologia 1 e 2 IRCCS AOU San Martino-IST; 🇮🇹 Genova, Italy

Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia; 🇮🇹 Milano, Italy

U.O. Ematologia Clinica - Azienda USL di Pescara; 🇮🇹 Pescara, Italy

Asst Degli Spedali Civili Di Brescia - Uo Ematologia; 🇮🇹 Brescia, Italy

Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo; 🇮🇹 Cagliari, Italy

Ospedale Niguarda " Ca Granda" - SC Ematologia; 🇮🇹 Milano, Italy

ULSS N.6 Osp. S. Bortolo; 🇮🇹 Vicenza, Italy

Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia; 🇮🇹 San Giovanni Rotondo, Italy

UO Ematologia con trapianto-Universita' degli Studi di Bari Aldo Moro; 🇮🇹 Bari, Italy

Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia; 🇮🇹 Alessandria, Italy

CTMO - Ematologia - Ospedale "Binaghi"; 🇮🇹 Cagliari, Italy

Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti; 🇮🇹 Genova, Italy

Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia; 🇮🇹 Roma, Italy

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica; 🇮🇹 Roma, Italy

Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli; 🇮🇹 Roma, Italy