Status:
ACTIVE_NOT_RECRUITING
Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
Detailed Description
This is a multicenter, prospective, translational study. Pharmacological treatments will not be object of the present study. Patients will follow the prescribed therapeutic indications according to re...
Eligibility Criteria
Inclusion
- Patients with new diagnosis of primary or secondary AML candidate to first line treatment with hypomethylating agents (specific for Cohort 1) Patients with primary or secondary AML who relapse after/during first line treatment with hypomethylating agents (specific for Cohort 2)
- for each cohort:
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged \>18 years
- Availability of clinical data
Exclusion
- Age \< 18 years
- AML M3 subtype according to FAB classification
Key Trial Info
Start Date :
July 19 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03789981
Start Date
July 19 2019
End Date
December 1 2025
Last Update
September 20 2024
Active Locations (14)
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1
AO Spedali Civili di Brescia
Brescia, BS, Italy, 25123
2
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, Italy, 47014
3
IRCCS Casa sollievo sofferenza
San Giovanni Rotondo, FOGGIA, Italy, 71013
4
IRCCS AOU S. Martino Genova
Genova, GE, Italy, 16132