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

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ClinicalTrials.gov Identifier: NCT03789981
Recruitment Status : Not yet recruiting
First Posted : December 31, 2018
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Genetic: Immunogenic profile

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 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.


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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Group/Cohort Intervention/treatment
At diagnosis
Immunogenic profile in patients affected by primary or secondary AML at diagnosis
Genetic: Immunogenic profile
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling

At relapse
Immunogenic profile in patients affected by primary or secondary AML at relapse
Genetic: Immunogenic profile
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Bone marrow (BM) and peripheral blood (PB) and saliva.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
AML patients affected by primary or secondary AML, at diagnosis or relapse
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789981


Contacts
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Contact: Oriana Nanni +390543739266 oriana.nanni@irst.emr.it

Locations
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Italy
Policlinico S.Orsola-Malpighi Not yet recruiting
Bologna, BO, Italy, 40138
Contact: Antonio Curti, MD         
AO Spedali Civili di Brescia Not yet recruiting
Brescia, BS, Italy, 25123
Contact: Erika Brolenghi, MD         
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Not yet recruiting
Meldola, FC, Italy, 47014
Contact: Giovanni Martinelli, MD    +390543739100    giovanni.martinelli@irst.emr.it   
Principal Investigator: Giovanni Martinelli, MD         
Sub-Investigator: Giorgia Simonetti, PhD         
Sub-Investigator: Marianna Norata, MD         
Sub-Investigator: Martina Ghetti, PhD         
IRCCS AOU S. Martino Genova Not yet recruiting
Genova, GE, Italy, 16132
Contact: Roberto Lemoli, MD         
Irccs Crob Not yet recruiting
Rionero in Vulture, PZ, Italy, 85028
Contact: Pellegrino Musto, MD         
Osp. S. Maria delle Croci Not yet recruiting
Ravenna, RA, Italy, 48121
Contact: Michela Rondoni, MD         
Ospedale degli Infermi Not yet recruiting
Rimini, RN, Italy, 47923
Contact: Anna Maria Mianulli, MD         
AOU Senese Not yet recruiting
Siena, SI, Italy, 53100
Contact: Monica Bocchia, MD         
Università di Torino Not yet recruiting
Orbassano, TO, Italy, 10043
Contact: Daniela Cilloni, MD         
AOU di Udine Not yet recruiting
Udine, Italy, 33010
Contact: Anna Candoni, MD         
Sponsors and Collaborators
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Investigators
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Study Chair: Giovanni Martinelli Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

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Responsible Party: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
ClinicalTrials.gov Identifier: NCT03789981     History of Changes
Other Study ID Numbers: IRSTB082
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori:
AML
Acute Myeloid Leukemia
Immunogenic profile
transcriptome analysis

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms