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NCT Number: NCT03789981

Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AO Spedali Civili di Brescia, Brescia, BS, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Age < 18 years
  • AML M3 subtype according to FAB classification

Treatment and study plan

Immunogenic profile

Genetic

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

Primary outcomes

  1. Evaluation of the Immunogenic profile of primary or secondary AML patients in according to the variations in expression of molecules involved in immune checkpoint

    Time frame: up to 30 months

    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

Secondary outcomes

  1. Investigation of the relationship between leukemia immunogenicity and immune checkpoint activation

    Time frame: up to 30 months

    the relationship between leukemia immunogenicity and immune checkpoint activation through transcriptome analysis of downstream pathways by flow cytometric analysis

  2. Investigation of the activation of immune checkpoint molecules

    Time frame: up to 30 months

    Investigation of the activation of immune checkpoint molecules under the selective pressure of hypomethylating agents treatment by gene expression profilling

  3. The investigation of the association of the immune checkpoint status with clinical outcomes

    Time frame: up to 30 months

    Investigation of the association of the immune checkpoint status with clinical outcomes (OS, PFS) estimated according to Kaplan-Meier.

  4. The investigation of the association of the immunogenic profile with clinical outcomes

    Time frame: up to 30 months

    Investigation of the association of the immunogenic profile with clinical outcomes (OS, PFS) estimated according to Kaplan-Meier.

Sponsors and collaborators

Lead sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Other

Registry information

Acronym: Immune-AML

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Dec 31, 2018
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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