Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia (Immune-AML)

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Status: Active, not recruiting

Conditions: Acute Myeloid Leukemia

Treatments: Genetic: Immunogenic profile

Study type: Observational

Funder types: Other

Identifiers

NCT03789981

IRSTB082

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

75 participants in 2 patient groups

At diagnosis

Description:

Immunogenic profile in patients affected by primary or secondary AML at diagnosis

Treatment:

Genetic: Immunogenic profile

At relapse

Description:

Immunogenic profile in patients affected by primary or secondary AML at relapse

Treatment:

Genetic: Immunogenic profile