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

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Recruiting
CT.gov ID
NCT03751917
Collaborator
(none)
100
28
55.6
3.6
0.1

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
  • Drug: Arsenic Trioxide

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

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Other
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)
Actual Study Start Date :
Apr 14, 2020
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. Number of patients developing secondary malignancies. [At a maximum of 5 years from study entry]

    3. Number of patients developing therapy-related myelodysplastic syndrome (tMDS). [At a maximum of 5 years from study entry]

    4. Number of patients developing acute myeloid leukemia (tAML). [At a maximum of 5 years from study entry]

    5. Number of patients who die. [At a maximum of 5 years from study entry]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Gruppo Italiano Malattie EMatologiche dell'Adulto
    ClinicalTrials.gov Identifier:
    NCT03751917
    Other Study ID Numbers:
    • APL0618
    First Posted:
    Nov 23, 2018
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2022