Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia (APL0618)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03751917|
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 26, 2018
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|
|Acute Promyelocytic Leukemia||Drug: Arsenic Trioxide|
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|
|Estimated Enrollment :||100 participants|
|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)|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2023|
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 Name: ATRA+ATO
- 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).
- 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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751917
|Contact: Paola Fazi||+39 email@example.com|
|Contact: Enrico Crea||+39 firstname.lastname@example.org|
|S.O.C. di Ematologia - A.O. - SS. Antonio e Biagio e Cesare Arrigo||Not yet recruiting|
|UO Ematologia con trapianto-Universita' degli Studi di Bari Aldo Moro||Not yet recruiting|
|Azienda Ospedaliera - Papa Giovanni XXIII||Not yet recruiting|
|Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia||Not yet recruiting|
|CTMO - Ematologia - Ospedale "Binaghi"||Not yet recruiting|
|A.O. Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - U.O. di Ematologia||Not yet recruiting|
|U.O.C. di Ematologia 1 e 2 IRCCS AOU San Martino-IST||Not yet recruiting|
|Fondazione IRCCS Ca' Granda Osp. Maggiore Policlinico UOC Oncoematologia||Not yet recruiting|
|Ospedale Niguarda " Ca Granda" - SC Ematologia||Not yet recruiting|
|U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele||Not yet recruiting|
|Azienda Ospedaliera "S.Gerardo"||Not yet recruiting|
|Napoli Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"||Not yet recruiting|
|Ospedali Riuniti "Villa Sofia-Cervello"||Not yet recruiting|
|U.O. Ematologia Clinica - Azienda USL di Pescara||Not yet recruiting|
|Universita' "Sapienza" - Dip Biotecnologie Cellulari - Divisione di Ematologia|
|Universita' Cattolica del Sacro Cuore - Policlinico A. Gemelli||Not yet recruiting|
|Contact: De Stefano|
|Universita' degli Studi - Policlinico di Tor Vergata||Not yet recruiting|
|Università degli studi di Tor Vergata||Not yet recruiting|
|Contact: Francesco Lo Coco|
|Principal Investigator: Francesco Lo Coco|
|stituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza||Not yet recruiting|
|San Giovanni Rotondo, Italy|
|Dipartimento di Oncologia Ematologia 2 A.O. Citta' della Salute S. G. Battista||Not yet recruiting|
|ULSS N.6 Osp. S. Bortolo||Not yet recruiting|
|Study Chair:||Francesco Lo Coco||Università degli Studi - Policlinico di Tor Vergata|