Status:
UNKNOWN
Long-term Safety Study of Arsenic Trioxide in Newly Diagnosed, Low-to-intermediate Risk Acute Promyelocytic Leukemia
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Acute Promyelocytic Leukemia
Eligibility:
All Genders
18+ years
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 o...
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...
Eligibility Criteria
Inclusion
- 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
- High risk APL (WBC count \> 10x103/µL)
- APL relapse
Key Trial Info
Start Date :
April 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03751917
Start Date
April 14 2020
End Date
December 1 2024
Last Update
January 4 2022
Active Locations (28)
Enter a location and click search to find clinical trials sorted by distance.
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