NCT03789981

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

July 19, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

5.4 years

First QC Date

November 8, 2018

Last Update Submit

September 18, 2024

Conditions

Acute Myeloid Leukemia

Keywords

AMLAcute Myeloid LeukemiaImmunogenic profiletranscriptome analysis

Outcome Measures

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

    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 Outcomes (4)

  • Investigation of the relationship between leukemia immunogenicity and immune checkpoint activation

    up to 30 months

  • Investigation of the activation of immune checkpoint molecules

    up to 30 months

  • The investigation of the association of the immune checkpoint status with clinical outcomes

    up to 30 months

  • The investigation of the association of the immunogenic profile with clinical outcomes

    up to 30 months

Study Arms (2)

At diagnosis

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

Genetic: Immunogenic profile

At relapse

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

Genetic: Immunogenic profile

Interventions

Immunogenic profileGENETIC

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

At diagnosisAt relapse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

AML patients affected by primary or secondary AML, at diagnosis or relapse

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

AO Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, 47014, Italy

Location

IRCCS Casa sollievo sofferenza

San Giovanni Rotondo, FOGGIA, 71013, Italy

Location

IRCCS AOU S. Martino Genova

Genova, GE, 16132, Italy

Location

Ospedale G. Da Saliceto

Piacenza, PC, 29121, Italy

Location

Irccs Crob

Rionero in Vulture, PZ, 85028, Italy

Location

Osp. S. Maria delle Croci

Ravenna, RA, 48121, Italy

Location

Ospedale degli Infermi

Rimini, RN, 47923, Italy

Location

AOU Senese

Siena, SI, 53100, Italy

Location

Università di Torino

Orbassano, TO, 10043, Italy

Location

AO Ordine Mauriziano di Torino

Torino, TO, 10128, Italy

Location

Azienda ULSS2 Marca Trevigiana

Treviso, TV, 31100, Italy

Location

AOU Maggiore della Carità

Novara, 28100, Italy

Location

AOU di Udine

Udine, 33010, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow (BM) and peripheral blood (PB) and saliva.

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Giovanni Martinelli

    Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

December 31, 2018

Study Start

July 19, 2019

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

September 20, 2024

Record last verified: 2024-09

Locations

IT(14)