Acute Myeloid LeukemiaRAMDNCT07867704
Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice
A study testing Bone marrow or peripheral blood withdrawal for test comparison in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia, Adult, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial summary
Prospective, multicenter study for the non-inferiority assessment of RAMD compared to GSS in determining the prognostic risk category according to ELN2022 for newly diagnosed AML patients on blood samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Myeloid Leukemia, Adult, Acute Promyelocytic Leukemia
- What is being tested?
- Bone marrow or peripheral blood withdrawal for test comparison
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients with de novo AML, includind Acute Promyelocytic Leukemia (APL), untreated, newly diagnosed according to WHO/ICC 2022 criteria based on conventional cytological, cytogenetic, and immunophenotypic disease characterization
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Availability of 1 aliquot of White Blood Cells pellet (≥3x106 WBCs or purified from ≥1.5mL of blood) from bone marrow (BM) or peripheral blood (PB) collected at diagnosis for RAMD. The aliquot should be stored at -90°C until shipment.
- Age ≥ 18 years
Who cannot join
- 1. Diagnosis of secondary AML
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice RAMD (Rapid AML Mutations Detection)
Prospective, multicenter study for the non-inferiority assessment of RAMD compared to GSS in determining the prognostic risk category according to ELN2022 for newly diagnosed AML patients on blood samples.
Read the detailed description
Prospective, multicenter study for the non-inferiority assessment of RAMD compared to GSS in determining the prognostic risk category according to ELN2022 for newly diagnosed AML patients.
The blood sample from bone marrow (BM) (or PB) for test RAMD, will be collected by the participating centers at diagnosis together with the sample for GSS. The gold-standard tests will be performed on the diagnostic sample at the collecting center according to local procedures, whereas the diagnostic sample for RAMD, as frozen WBCs pellet, will be processed upon arrival at the Central Laboratory according to the RAMD protocol. The results of GSS and RAMD will be entered independently into the eCRF as soon as they become available and subsequently compared for the purposes of the study.
- Being tested
- Bone marrow or peripheral blood withdrawal for test comparison
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Promyelocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow or peripheral blood withdrawal for test comparisonOther
The blood sample from bone marrow (BM) (or PB) for test RAMD will be collected by the participating centers at diagnosis. The gold-standard tests (GSS) will be performed according to local procedures, whereas the diagnostic sample for RAMD, as frozen WBCs pellet, will be processed upon arrival at the Central Laboratory. The results of GSS and RAMD will be subsequently compared.
| Study group | Role | What they receive |
|---|---|---|
| Non-inferiority assessment of RAMD compared to GSS | Other | The blood sample from bone marrow (or PB) will be collected at diagnosis for test RAMD Receives: Other: Bone marrow or peripheral blood withdrawal for test comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic risk classification
Proportion of patients whose prognostic risk classification according to the ELN2022 criteria (Favorable/Low-risk, Intermediate/Intermediate-risk, Adverse/High-risk) is concordant between the investigational method RAMD and GSS, to demonstrate non-inferiority of RAMD versus GSS.
Measured: at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niccolo Bartalucci, Principal investigator, AOU Careggi CRIMM LAB Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867704
- Sponsor's protocol ID
- AML3126
- Acronym
- RAMD
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice RAMD (Rapid AML Mutations Detection)
- ClinicalTrials.gov ID
- NCT07867704
- Acronym / sponsor ID
- RAMD / AML3126
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 9 Oct 2026 (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.
Prospective, multicenter study for the non-inferiority assessment of RAMD compared to GSS in determining the prognostic risk category according to ELN2022 for newly diagnosed AML patients on blood samples.
Detailed description
Prospective, multicenter study for the non-inferiority assessment of RAMD compared to GSS in determining the prognostic risk category according to ELN2022 for newly diagnosed AML patients.
The blood sample from bone marrow (BM) (or PB) for test RAMD, will be collected by the participating centers at diagnosis together with the sample for GSS. The gold-standard tests will be performed on the diagnostic sample at the collecting center according to local procedures, whereas the diagnostic sample for RAMD, as frozen WBCs pellet, will be processed upon arrival at the Central Laboratory according to the RAMD protocol. The results of GSS and RAMD will be entered independently into the eCRF as soon as they become available and subsequently compared for the purposes of the study.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-inferiority assessment of RAMD compared to GSS | Other | Other: Bone marrow or peripheral blood withdrawal for test comparisonThe blood sample from bone marrow (or PB) will be collected at diagnosis for test RAMD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with de novo AML, includind Acute Promyelocytic Leukemia (APL), untreated, newly diagnosed according to WHO/ICC 2022 criteria based on conventional cytological, cytogenetic, and immunophenotypic disease characterization
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Availability of 1 aliquot of White Blood Cells pellet (≥3x106 WBCs or purified from ≥1.5mL of blood) from bone marrow (BM) or peripheral blood (PB) collected at diagnosis for RAMD. The aliquot should be stored at -90°C until shipment.
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- 1. Diagnosis of secondary AML
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 |
|---|---|---|
| Bone marrow or peripheral blood withdrawal for test comparisonThe blood sample from bone marrow (BM) (or PB) for test RAMD will be collected by the participating centers at diagnosis. The gold-standard tests (GSS) will be performed according to local procedures, whereas the diagnostic sample for RAMD, as frozen WBCs pellet, will be processed upon arrival at the Central Laboratory. The results of GSS and RAMD will be subsequently compared. | Other | Non-inferiority assessment of RAMD compared to GSS |
Primary outcome
Prognostic risk classification
Time frame: at 24 months
Proportion of patients whose prognostic risk classification according to the ELN2022 criteria (Favorable/Low-risk, Intermediate/Intermediate-risk, Adverse/High-risk) is concordant between the investigational method RAMD and GSS, to demonstrate non-inferiority of RAMD versus GSS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
Niccolo Bartalucci principal investigator
AOU Careggi CRIMM LAB Firenze
Questions about this trial
What is this clinical trial studying?
A study testing Bone marrow or peripheral blood withdrawal for test comparison in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia, Adult, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paola Fazi (00390670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic risk classification (time frame: at 24 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 9 Oct 2026.