Acute Myeloid Leukemia Clinical Trial
— Immune-AMLOfficial title:
Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
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 |
This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori |
Italy,
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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