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

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ClinicalTrials.gov Identifier: NCT03751917
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Tracking Information
First Submitted Date November 21, 2018
First Posted Date November 22, 2018
Last Update Posted Date November 26, 2018
Estimated Study Start Date January 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2018)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03751917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 21, 2018)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia
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)
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.

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
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Acute Promyelocytic Leukemia
Intervention 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
Study Groups/Cohorts 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.
Intervention: Drug: Arsenic Trioxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 21, 2018)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Paola Fazi +39 0670390514 p.fazi@gimema.it
Contact: Enrico Crea +39 0670390514 e.crea@gimema.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03751917
Other Study ID Numbers APL0618
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborators Not Provided
Investigators
Study Chair: Francesco Lo Coco Università degli Studi - Policlinico di Tor Vergata
PRS Account Gruppo Italiano Malattie EMatologiche dell'Adulto
Verification Date November 2018