Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia
APL0618
A Long-Term Retrospective and Prospective Safety Study of Arsenic Trioxide in Patients With Newly Diagnosed, Low- to Intermediate-Risk Acute Promyelocytic Leukemia (APL)
1 other identifier
observational
100
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedStudy Start
First participant enrolled
April 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 4, 2022
December 1, 2021
4.6 years
November 21, 2018
December 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Number of unexpected serious adverse events (SAEs).
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 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
Study Arms (1)
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.
Interventions
This is an observational study. Patients who have received or are receiving all trans retinoic acid (ATRA) + Arsenic Trioxide will be followed and analyzed.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- High risk APL (WBC count \> 10x103/µL)
- APL relapse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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
Milan, Italy
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan, Italy
Ospedale Niguarda " Ca Granda" - SC Ematologia
Milan, 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
Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia
Roma, Italy
Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
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, Italy
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2018
First Posted
November 23, 2018
Study Start
April 14, 2020
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 4, 2022
Record last verified: 2021-12