Automated vs Manual Flow-cytometry Gating for Measurable Residual Disease in Acute Myeloid Leukaemia (DUALFLOW)

University Hospital of Bordeaux

Status: Not yet enrolling

Conditions: Leukemia, Myeloid, Acute

Treatments: Diagnostic Test: Conventional gating; Diagnostic Test: Automated gating

Study type: Observational

Funder types: Other

Identifiers

NCT07269067

CHUBX 2025/033

Details and patient eligibility

About

This retrospective multicentre cohort evaluates the agreement of measurable residual disease (MRD) detection in acute myeloid leukaemia (AML) using two flow-cytometry gating approaches. Manual expert gating is compared with an unsupervised FlowSOM clustering algorithm across post-induction and post-consolidation samples from 50 adults and 10 paediatric patients treated at Bordeaux University Hospital. The primary hypothesis states that unsupervised gating detects MRD ≥ 0.1 % with sensitivity and specificity comparable to manual gating.

Full description

Acute myeloid leukaemia remains associated with high relapse rates despite complete remission after induction chemotherapy. Sensitive identification of residual leukaemic blasts (MRD) guides risk-adapted therapy. Flow cytometry is applicable to nearly all patients but relies on operator-dependent manual gating, which may lack reproducibility when rare or immunophenotypically atypical blasts are present. A data-driven alternative based on FlowSOM clustering was developed at Bordeaux to overcome these limitations. DualFlow retrospectively analyses paired flow-cytometry standard (FCS) files from 60 AML patients (≈ 100 MRD determinations) drawn from the DATAML Bordeaux adult database and the paediatric haemato-oncology service. Files are distributed to three partner centers for blinded re-analysis. Each sample undergoes: (1) conventional manual gating in two expert centers; (2) unsupervised FlowSOM gating in one center; (3) molecular MRD assessment when available. Primary analysis calculates sensitivity, specificity, predictive values and Cohen/Fleiss kappa for MRD ≥ 0.1 %. Secondary analyses include concordance with molecular MRD, Bland-Altman and correlation for MRD 0.01-0.1 %, impact on relapse-free and overall survival using Kaplan-Meier and Cox models, and operator reproducibility for manual gating. Covariate effects (age, cytogenetics, molecular risk, treatment) are explored through stratified and multivariable methods. No additional interventions or specimens are collected; only de-identified FCS files and routine clinical data are used.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of acute myeloid leukaemia per ELN 2022
• Age ≥ 18 years (adult cohort) or 0-20 years (paediatric cohort)
• Inclusion in DATAML Bordeaux database or paediatric haemato-oncology records
• Available flow-cytometry MRD data post-induction and post-consolidation 1
• Non-opposition or consent for secondary use of data

Exclusion criteria

• AML subtypes M3, M6 or M7
• Acute leukaemia of ambiguous lineage
• Missing or unusable flow-cytometry files for required time points

Trial design

60 participants in 2 patient groups

Adult AML cohort

Description:

Adults ≥ 18 years with ELN-defined AML enrolled in DATAML Bordeaux, possessing flow-cytometry MRD data after induction and consolidation 1

Treatment:

Diagnostic Test: Automated gating

Diagnostic Test: Conventional gating

Paediatric AML cohort

Description:

Children and adolescents 0-18 years managed in the paediatric haemato-oncology unit, with analogous MRD flow-cytometry data

Treatment:

Diagnostic Test: Automated gating

Diagnostic Test: Conventional gating