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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 : Recruiting
First Posted : December 31, 2018
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Tracking Information
First Submitted Date November 8, 2018
First Posted Date December 31, 2018
Last Update Posted Date April 21, 2020
Actual Study Start Date July 19, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 21, 2018)
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
Official Title Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
Brief Summary This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Bone marrow (BM) and peripheral blood (PB) and saliva.
Sampling Method Probability Sample
Study Population AML patients affected by primary or secondary AML, at diagnosis or relapse
Condition Acute Myeloid Leukemia
Intervention Genetic: Immunogenic profile
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling
Study Groups/Cohorts
  • At diagnosis
    Immunogenic profile in patients affected by primary or secondary AML at diagnosis
    Intervention: Genetic: Immunogenic profile
  • At relapse
    Immunogenic profile in patients affected by primary or secondary AML at relapse
    Intervention: Genetic: Immunogenic profile
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 21, 2018)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Oriana Nanni +390543739266 oriana.nanni@irst.emr.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03789981
Other Study ID Numbers IRSTB082
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Sponsor Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Collaborators Not Provided
Investigators
Study Chair: Giovanni Martinelli Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
PRS Account Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Verification Date April 2020