Acute Myeloid LeukemiaImmune-AMLNCT03789981
Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 14 sites in Italy.
Trial summary
This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Immunogenic profile
- How many people
- 75 participants
- Where
- 14 sitesItaly
- Study dates
- 19 Jul 2019to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AML patients affected by primary or secondary AML, at diagnosis or relapse
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- AML M3 subtype according to FAB classification
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
AO Spedali Civili di Brescia
Brescia, BS, 25123
IRCCS AOU S. Martino Genova
Genova, GE, 16132
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, 47014
AOU Maggiore della Carità
Novara, 28100
Università di Torino
Orbassano, TO, 10043
Ospedale G. Da Saliceto
Piacenza, PC, 29121
Osp. S. Maria delle Croci
Ravenna, RA, 48121
Ospedale degli Infermi
Rimini, RN, 47923
Irccs Crob
Rionero in Vulture, PZ, 85028
IRCCS Casa sollievo sofferenza
San Giovanni Rotondo, FOGGIA, 71013
AOU Senese
Siena, SI, 53100
AO Ordine Mauriziano di Torino
Torino, TO, 10128
Azienda ULSS2 Marca Trevigiana
Treviso, TV, 31100
AOU di Udine
Udine, 33010
About this study
This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
Read the 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Immunogenic profile
- Keywords
- AML, Acute Myeloid Leukemia, Immunogenic profile, transcriptome analysis
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunogenic profileGenetic
RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling
| Study group | Role | What they receive |
|---|---|---|
| At diagnosis | Immunogenic profile in patients affected by primary or secondary AML at diagnosis Receives: Genetic: Immunogenic profile | |
| At relapse | Immunogenic profile in patients affected by primary or secondary AML at relapse Receives: Genetic: Immunogenic profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 months
Secondary outcomes (4)
Investigation of the relationship between leukemia immunogenicity and immune checkpoint activation
the relationship between leukemia immunogenicity and immune checkpoint activation through transcriptome analysis of downstream pathways by flow cytometric analysis
Measured: up to 30 months
Investigation of the activation of immune checkpoint molecules
Investigation of the activation of immune checkpoint molecules under the selective pressure of hypomethylating agents treatment by gene expression profilling
Measured: up to 30 months
The investigation of the association of the immune checkpoint status with clinical outcomes
Investigation of the association of the immune checkpoint status with clinical outcomes (OS, PFS) estimated according to Kaplan-Meier.
Measured: up to 30 months
The investigation of the association of the immunogenic profile with clinical outcomes
Investigation of the association of the immunogenic profile with clinical outcomes (OS, PFS) estimated according to Kaplan-Meier.
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start19 Jul 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Martinelli, Study chair, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789981
- Sponsor's protocol ID
- IRSTB082
- Acronym
- Immune-AML
- Status last verified
- Sep 2024
- First submitted
- 8 Nov 2018
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03789981
- Acronym / sponsor ID
- Immune-AML / IRSTB082
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, Acute Myeloid Leukemia, Immunogenic profile, transcriptome analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 31 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| At diagnosis | – | Genetic: Immunogenic profileImmunogenic profile in patients affected by primary or secondary AML at diagnosis |
| At relapse | – | Genetic: Immunogenic profileImmunogenic profile in patients affected by primary or secondary AML at relapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AML patients affected by primary or secondary AML, at diagnosis or relapse
Key inclusion criteria (5 listed)
- 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)
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged >18 years
- Availability of clinical data
Key exclusion criteria (2 listed)
- Age < 18 years
- AML M3 subtype according to FAB classification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunogenic profileRNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling | Genetic | At diagnosis, At relapse |
Primary outcome
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
4 secondary outcomes
Investigation of the relationship between leukemia immunogenicity and immune checkpoint activation
Time frame: up to 30 months
Investigation of the activation of immune checkpoint molecules
Time frame: up to 30 months
The investigation of the association of the immune checkpoint status with clinical outcomes
Time frame: up to 30 months
The investigation of the association of the immunogenic profile with clinical outcomes
Time frame: up to 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Martinelli study chair
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.