Feasibility and Efficiency Study for the Implementation of a New Screening Method for Patients With Acute Myeloid Leukemia, in Laboratory Practice

NCT07867704 | Not Yet Recruiting

• 1 other identifier: AML3126
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Myeloid Leukemia; Acute Myeloid Leukemia, Adult; Acute Promyelocytic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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.

  at 24 months

Study Arms (1)

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

Other: Bone marrow or peripheral blood withdrawal for test comparison

Interventions

Bone marrow or peripheral blood withdrawal for test comparison OTHER

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.

Non-inferiority assessment of RAMD compared to GSS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. Diagnosis of secondary AML

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Promyelocytic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Niccolo Bartalucci

  AOU Careggi CRIMM LAB Firenze

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Fazi

CONTACT

00390670390528; p.fazi@gimema.it

Enrico Crea

CONTACT

00390670390514; e.crea@gimema.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 9, 2026

Record last verified: 2026-10