Acute Promyelocytic LeukemiaAPL0618NCT03751917
Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia
An observational study of Acute Promyelocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 28 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Promyelocytic Leukemia
- What is being tested?
- Arsenic Trioxide
- How many people
- 100 participants
- Where
- 28 sitesItaly
- Study dates
- 14 Apr 2020to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- High risk APL (WBC count > 10x103/µL)
- APL relapse
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Italy28 sites, 28 recruiting
- Recruiting
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria
Lorella Depaoli
- Recruiting
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari
Paola Carluccio, 3383401921, paola.carluccio@policlinico.ba.it
- Not yet recruiting
UO Ematologia con trapianto-Universita' degli Studi di Bari Aldo Moro
Bari
Specchia
- Not yet recruiting
Azienda Ospedaliera - Papa Giovanni XXIII
Bergamo
Rambaldi
- Recruiting
Asst Degli Spedali Civili Di Brescia - Uo Ematologia
Brescia
Erika Borlenghi
- Recruiting
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari
Claudio Romani, 3387938629, claromani@tiscali.it
- Not yet recruiting
CTMO - Ematologia - Ospedale "Binaghi"
Cagliari
Cabras
- Recruiting
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
Castelfranco Veneto
Roberto Sartori
- Not yet recruiting
A.O. Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - U.O. di Ematologia
Catanzaro
Molica
- Recruiting
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
Genova
Germana Beltrami, 3495215547, germana.beltrami@hsanmartino.it
- Not yet recruiting
U.O.C. di Ematologia 1 e 2 IRCCS AOU San Martino-IST
Genova
Angelucci
- Not yet recruiting
Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico UOC Oncoematologia
Milan
Cortelezzi
- Recruiting
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan
Fabio Ciceri
- Recruiting
Ospedale Niguarda " Ca Granda" - SC Ematologia
Milan
Valentina Mancini
- Not yet recruiting
Azienda Ospedaliera "S.Gerardo"
Monza
Pioltelli
- Recruiting
Napoli Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Naples
Felicetto Ferrara
- Recruiting
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
Francesco Fabbiano, 3341149462, ffabbiano@libero.it
- Not yet recruiting
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara
Pescara
- Recruiting
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali
Roma
Maria Teresa Voso
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma
Patrizia Chiusolo, 3355267999, patrizia.chiusolo@Unicatt.it
- Not yet recruiting
Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia
Roma
Foà
- Not yet recruiting
Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma
De Stefano
- Recruiting
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma
Massimo Breccia, 3398972422, breccia@bce.uniroma1.it
- Recruiting
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo
Lorella Melillo
- Recruiting
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino
Stefano D'ardia, 3484745268, sdardia@cittadellasalute.to.it
- Not yet recruiting
Dipartimento di Oncologia Ematologia 2 A.O. Citta' della Salute S. G. Battista
Torino
Vitolo
- Recruiting
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza
Eros Di bona, 3483429883, eros.dibona@aulss8.veneto.it
- Not yet recruiting
ULSS N.6 Osp. S. Bortolo
Vicenza
Ruggeri
About this study
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)
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.
Read the 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.
- Conditions
- Acute Promyelocytic Leukemia
- Being tested
- Arsenic Trioxide
- Keywords
- Acute promyelocytic leukemia, Adults, Arsenic trioxide
- Medical subject headings
- Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arsenic TrioxideDrug
Also called ATRA+ATO
This is an observational study. Patients who have received or are receiving all trans retinoic acid (ATRA) + Arsenic Trioxide will be followed and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Arsenic Trioxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At a maximum of 5 years from study entry
Secondary outcomes (5)
Number of unexpected serious adverse events (SAEs).
Including grading and relationship as documented in the study.
Measured: At a maximum of 5 years from study entry
Number of patients developing secondary malignancies.
Measured: At a maximum of 5 years from study entry
Number of patients developing therapy-related myelodysplastic syndrome (tMDS).
Measured: At a maximum of 5 years from study entry
Number of patients developing acute myeloid leukemia (tAML).
Measured: At a maximum of 5 years from study entry
Number of patients who die.
Measured: At a maximum of 5 years from study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start14 Apr 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Promyelocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751917
- Sponsor's protocol ID
- APL0618
- Acronym
- APL0618
- Status last verified
- Dec 2021
- First submitted
- 21 Nov 2018
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03751917
- Acronym / sponsor ID
- APL0618 / APL0618
- Conditions
- Acute Promyelocytic Leukemia
- Keywords
- Acute promyelocytic leukemia, Adults, Arsenic trioxide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APL patients | – | Drug: Arsenic TrioxideThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- High risk APL (WBC count > 10x103/µL)
- APL relapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arsenic TrioxideAlso: ATRA+ATOThis is an observational study. Patients who have received or are receiving all trans retinoic acid (ATRA) + Arsenic Trioxide will be followed and analyzed. | Drug | APL patients |
Primary outcome
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).
5 secondary outcomes
Number of unexpected serious adverse events (SAEs).
Time frame: 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
Number of patients developing therapy-related myelodysplastic syndrome (tMDS).
Time frame: 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
Number of patients who die.
Time frame: At a maximum of 5 years from study entry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- GIMEMA Foundation websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Promyelocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 28 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (+39 0670390514, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.