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Starting soon Observational

Proof of Concept for Real-time Multicentric Monitoring of MRD by PET and ctDNA in Aggressive B-Cell Lymphomas

NCT07514715 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-06-30
Last updated
2026-06-11

Condition(s) studied

Aggressive B-cell Lymphomas

Investigational drug(s) / intervention(s)

blood test

blood test: Three blood tests will be performed (one before treatment, one at mid treatment, and one at the end of treatment) for ctDNA analysis.

Study summary

RT4 (REAL TIME TAILORED THERAPY) study was designed as a national, multicenter proof of concept aiming to demonstrate the technical and operational capacity of the French Connect network and the Positron Emission Tomography (PET) review network to ensure, within a coordinated framework, real time MINIMAL RESIDUAL DISEASE (MRD) monitoring through ctDNA analysis and centralized review of PET imaging.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion criteria Participants must meet all of the following criteria to be included in the study: 1. Participant who understands and voluntarily signs an informed consent form prior to any study-specific assessment or procedure. 2. Age 18 or older at the time of signing the Informed Consent Form (ICF) 3. Histologically confirmed diagnosis, according to the WHO 2022 classification, of any of the following lymphomas: Aggressive B-cell lymphoma, including: * Diffuse large B-cell lymphoma, unspecified (DLBCL not specified) * High-grade B-cell lymphoma (LBHG), including: 1. With rearrangements of the MYC and BCL2 and/or BCL6 genes (double/triple hit) 2. Unspecified (i.e., no double/triple rearrangement) * Primary B-cell lymphoma of the mediastinum (PMBL) * Transformed indolent B-cell lymphoma, including: 1. Transformed follicular lymphoma (LFt) 2. Transformed marginal zone lymphoma (t-MZL) 3. Transformed, unspecified nodal or splenic B-cell lymphomas (NOS) 4. Presence of a measurable disease on pre-therapeutic PET imaging, defined as at least one two-dimensional measurable nodal lesion, defined as \> 1.5 cm in its largest dimension (and FDG-greedy lesion), or at least one two-dimensional measurable extranodal lesion, defined as \> 1.0 cm in its largest dimension (and FDG-hungry lesion). 5. Requiring standard first-line systemic treatment with curative intent 6. Person covered by a social security scheme 7. Person able to understand and speak French. Exclusion criteria Participants who meet any of the criteria below will not be eligible for inclusion / should be excluded from the study: 1. Systemic anticancer treatment of current lymphoma prior to inclusion in the study. All participants must be previously untreated for current lymphoma. Note: Short-term corticosteroid therapy (e.g., for symptom control or as part of diagnostic workup) is allowed prior to inclusion and is not an exclusion criterion. 2. Lymphomas associated with an immuno-privileged site (e.g., primary central nervous system lymphoma, primary testicular lymphoma, primary vitreoretinal lymphoma). 3. Absence of mandatory blood sampling for the analysis of circulating tumor DNA (ctDNA) during screening (pre-therapeutic sampling). 4. Absence of 18F-FDG PET examination performed within 2 months ≤ the date of signing the consent (mandatory pre-therapeutic PET imaging). 5. Pregnant, intending to be pregnant, or breastfeeding woman of childbearing potential 6. Any significant medical condition, laboratory abnormality, or psychiatric illness that may interfere with participation in this clinical study (in the opinion of the investigator) 7. Person deprived of liberty by judicial or administrative decision 8. Person hospitalized without their consent 9. Adult under legal protection

Primary outcome measure(s)

  • The primary endpoint is the proportion of participants for whom MRD results are delivered within these timelines at the predefined interim treatment response assessment. — at interim timepoint, after Cycle 4 (each cycle is 14 or 21 days)
    The primary objective of the study is to assess the feasibility of providing investigators with MRD results for participants with previously untreated aggressive B cell lymphomas at the time of the predefined interim response assessment, within strict timelines: * no more than 14 calendar days from blood collection for ctDNA results, and * no more than 7 calendar days after the imaging examination for the centralized PET review results.

Trial sites (30)

FacilityCityRegionStatus
CHU D'AMIENS - HOPITAL SUD - Service Hématologie Clinique et Thérapie Cellulaire Amiens France
CHU D'ANGERS - Service des Maladies du Sang Angers France
CH D'AVIGNON - HOPITAL HENRI DUFFAUT - Service d'Onco-Hématologie Avignon France
CHU JEAN MINJOZ - Service Hématologie Besançon France
CHU ESTAING - Service Thérapie Cellulaire et Hématologie Clinique Clermont-Ferrand France
HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes Créteil France
CHU DIJON BOURGOGNE - Service Hématologie Clinique Dijon France
CHD DE VENDEE - Service Hématologie La Roche-sur-Yon France
CHU DE GRENOBLE - Service Hématologie La Tronche France
CH DE VERSAILLES - HOPITAL ANDRE MIGNOT - Service Hématologie Adolescents et Jeunes Adultes Le Chesnay France
HOPITAL SAINT VINCENT-DE-PAUL - Service Hématologie Clinique Lille France
CHU DE LILLE - HOPITAL CLAUDE HURIEZ - Service des Maladies du Sang Lille France
CENTRE LEON BERARD - Service Hématologie Lyon France
CHU DE MONTPELLIER - Département d'Hématologie Clinique Montpellier France
CHU DE NANTES - Service Hématologie Nantes France
CHU ORLEANS - Service Oncologie Médicale Orléans France
HOPITAL COCHIN - Hématologie clinique Paris France
HOPITAL SAINT-LOUIS - Service Hématologie Adolescents et Jeunes Adultes Paris France
HOPITAL DE LA PITIE SALPETRIERE - Service Hématologie Clinique Paris France
HOPITAL NECKER - Service Hématologie Adultes Paris France
CHU DE BORDEAUX - HOPITAL HAUT-LEVEQUE - CENTRE FRANCOIS MAGENDIE - Service d'Hématologie et Thérapie Cellulaire Pessac France
CHU LYON-SUD - Hématologie Clinique Pierre-Bénite France
CHU DE POITIERS - HOPITAL DE LA MILETRIE - Service d'Oncologie Hématologique et Thérapie Cellulaire Poitiers France
CHU DE REIMS - HOPITAL ROBERT DEBRE - Service Hématologie Reims France
CHU PONTCHAILLOU - Hématologie Clinique Rennes France
CENTRE HENRI BECQUEREL - Service Hématologie Rouen France
INSTITUT CURIE - SITE SAINT-CLOUD - Service Hématologie Saint-Cloud France
IUCT ONCOPOLE - Service Hématologie Toulouse France
CHRU NANCY - HÔPITAL BRABOIS - Service Hématologie Vandœuvre-lès-Nancy France
GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique Villejuif France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07514715 on ClinicalTrials.gov ↗ ← All trials in France