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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03789981
Other study ID # IRSTB082
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 19, 2019
Est. completion date December 2021

Study information

Verified date February 2021
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Oriana Nanni
Phone +390543739266
Email oriana.nanni@irst.emr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.


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 regular clinical practice. Biological samples and clinical data will be collected at fixed timepoints. Aim of the study is to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression. A total of 75 AML patients affected by primary or secondary AML, at diagnosis ( 45 patients) or relapse (30 patients) will be enrolled in the protocol (18 months for patient enrolment). Blood,BM and saliva samples will be collected from each patients; for patients enrolled at diagnosis, samples will be collected before and after treatment with hypomethylating agents.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 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: 2. Participant is willing and able to give informed consent for participation in the study 3. Male or Female, aged >18 years 4. Availability of clinical data Exclusion Criteria: 1. Age < 18 years 2. AML M3 subtype according to FAB classification

Study Design


Intervention

Genetic:
Immunogenic profile
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling

Locations

Country Name City State
Italy AO Spedali Civili di Brescia Brescia BS
Italy IRCCS AOU S. Martino Genova Genova GE
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola FC
Italy AOU Maggiore della Carità Novara
Italy Università di Torino Orbassano TO
Italy Ospedale G. Da Saliceto Piacenza PC
Italy Osp. S. Maria delle Croci Ravenna RA
Italy Ospedale degli Infermi Rimini RN
Italy Irccs Crob Rionero in Vulture PZ
Italy IRCCS Casa sollievo sofferenza San Giovanni Rotondo Foggia
Italy AOU Senese Siena SI
Italy AO Ordine Mauriziano di Torino Torino TO
Italy Azienda ULSS2 Marca Trevigiana Treviso TV
Italy AOU di Udine Udine

Sponsors (1)

Lead Sponsor Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of the Immunogenic profile of primary or secondary AML patients in according to the variations in expression of molecules involved in immune checkpoint The immunogenic profile of AML cases obtained by NeoAgprediction will be related with established biological and clinical parameters (including karyotype, percentage of blasts, clinical outcome) performing RNA sequencing (RNAseq) and whole exome sequencing (WES) analysis up to 30 months
Secondary Investigation of the relationship between leukemia immunogenicity and immune checkpoint activation the relationship between leukemia immunogenicity and immune checkpoint activation through transcriptome analysis of downstream pathways by flow cytometric analysis up to 30 months
Secondary Investigation of the activation of immune checkpoint molecules Investigation of the activation of immune checkpoint molecules under the selective pressure of hypomethylating agents treatment by gene expression profilling up to 30 months
Secondary The investigation of the association of the immune checkpoint status with clinical outcomes Investigation of the association of the immune checkpoint status with clinical outcomes (OS, PFS) estimated according to Kaplan-Meier. up to 30 months
Secondary The investigation of the association of the immunogenic profile with clinical outcomes Investigation of the association of the immunogenic profile with clinical outcomes (OS, PFS) estimated according to Kaplan-Meier. up to 30 months
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