Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia (APL0618)

December 31, 2021 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

A Long-Term Retrospective and Prospective Safety Study of Arsenic Trioxide in Patients With Newly Diagnosed, Low- to Intermediate-Risk Acute Promyelocytic Leukemia (APL)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • Recruiting
        • Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
        • Contact:
          • Lorella Depaoli
      • Bari, Italy
        • Recruiting
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
        • Contact:
      • Bari, Italy
        • Not yet recruiting
        • UO Ematologia con trapianto-Universita' degli Studi di Bari Aldo Moro
        • Contact:
          • Specchia
      • Bergamo, Italy
        • Not yet recruiting
        • Azienda Ospedaliera - Papa Giovanni XXIII
        • Contact:
          • Rambaldi
      • Brescia, Italy
        • Recruiting
        • Asst Degli Spedali Civili Di Brescia - Uo Ematologia
        • Contact:
          • Erika Borlenghi
      • Cagliari, Italy
        • Recruiting
        • Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
        • Contact:
      • Cagliari, Italy
        • Not yet recruiting
        • CTMO - Ematologia - Ospedale "Binaghi"
        • Contact:
          • Cabras
      • Castelfranco Veneto, Italy
        • Recruiting
        • U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
        • Contact:
          • Roberto Sartori
      • Catanzaro, Italy
        • Not yet recruiting
        • A.O. Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - U.O. di Ematologia
        • Contact:
          • Molica
      • Genova, Italy
        • Recruiting
        • Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
        • Contact:
      • Genova, Italy
        • Not yet recruiting
        • U.O.C. di Ematologia 1 e 2 IRCCS AOU San Martino-IST
        • Contact:
          • Angelucci
      • Milano, Italy
        • Not yet recruiting
        • Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico UOC Oncoematologia
        • Contact:
          • Cortelezzi
      • Milano, Italy
        • Recruiting
        • Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
        • Contact:
          • Fabio Ciceri
      • Milano, Italy
        • Recruiting
        • Ospedale Niguarda " Ca Granda" - SC Ematologia
        • Contact:
          • Valentina Mancini
      • Monza, Italy
        • Not yet recruiting
        • Azienda Ospedaliera "S.Gerardo"
        • Contact:
          • Pioltelli
      • Naples, Italy
        • Recruiting
        • Napoli Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
        • Contact:
          • Felicetto Ferrara
      • Palermo, Italy
        • Recruiting
        • Ospedali Riuniti "Villa Sofia-Cervello"
        • Contact:
      • Pescara, Italy
        • Not yet recruiting
        • U.O. Ematologia Clinica - Azienda USL di Pescara
        • Contact:
          • Pescara
      • Roma, Italy
        • Recruiting
        • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
        • Contact:
      • Roma, Italy
        • Recruiting
        • Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
      • Roma, Italy
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
        • Contact:
      • Roma, Italy
        • Not yet recruiting
        • Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia
        • Contact:
          • Foà
      • Roma, Italy
        • Not yet recruiting
        • Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli
        • Contact:
          • De Stefano
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
        • Contact:
          • Lorella Melillo
      • Torino, Italy
        • Recruiting
        • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
        • Contact:
      • Torino, Italy
        • Not yet recruiting
        • Dipartimento di Oncologia Ematologia 2 A.O. Citta' della Salute S. G. Battista
        • Contact:
          • Vitolo
      • Vicenza, Italy
        • Recruiting
        • Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
        • Contact:
      • Vicenza, Italy
        • Not yet recruiting
        • ULSS N.6 Osp. S. Bortolo
        • Contact:
          • Ruggeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Source Population for the study is patients included in existing multinational disease registries for APL in Europe. APL registries collect real-world data on APL demographics and provide information on disease characteristics, treatment patterns and long-term effects. Participating physicians are not subject to any instructions with regard to the diagnosis and therapy of their patients. All patient treatment is carried out within routine clinical practice at the discretion of the physician and according to existing treatment guidelines.

Data will be extracted from the registries for all patients meeting the above inclusion and exclusion criteria to provide the study population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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:
  • ATRA+ATO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of grade III/IV (Common Terminology Criteria for Adverse Events (CTCAE) v4.03) adverse events of special interest (AESI).
Time Frame: 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).
At a maximum of 5 years from study entry

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of unexpected serious adverse events (SAEs).
Time Frame: At a maximum of 5 years from study entry
Including grading and relationship as documented in the study.
At a maximum of 5 years from study entry
Number of patients developing secondary malignancies.
Time Frame: At a maximum of 5 years from study entry
At a maximum of 5 years from study entry
Number of patients developing therapy-related myelodysplastic syndrome (tMDS).
Time Frame: At a maximum of 5 years from study entry
At a maximum of 5 years from study entry
Number of patients developing acute myeloid leukemia (tAML).
Time Frame: At a maximum of 5 years from study entry
At a maximum of 5 years from study entry
Number of patients who die.
Time Frame: At a maximum of 5 years from study entry
At a maximum of 5 years from study entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2020

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 4, 2022

Last Update Submitted That Met QC Criteria

December 31, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APL0618

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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