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

Starting soon

Conditions studied: Aggressive B-cell Lymphomas

In brief

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.

Key facts

Study ID

NCT07514715

Run by

The Lymphoma Academic Research Organisation

People needed

129

Starts

2026-06-30

Expected to finish

2028-10-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must meet all of the following criteria to be included in the study:
• Participant who understands and voluntarily signs an informed consent form prior to any study-specific assessment or procedure.
• Age 18 or older at the time of signing the Informed Consent Form (ICF)
• 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:
• With rearrangements of the MYC and BCL2 and/or BCL6 genes (double/triple hit)
• Unspecified (i.e., no double/triple rearrangement)
• Primary B-cell lymphoma of the mediastinum (PMBL)
• Transformed indolent B-cell lymphoma, including:
• Transformed follicular lymphoma (LFt)
• Transformed marginal zone lymphoma (t-MZL)
• Transformed, unspecified nodal or splenic B-cell lymphomas (NOS)
• 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).
• Requiring standard first-line systemic treatment with curative intent
• Person covered by a social security scheme
• 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:
• 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.
• Lymphomas associated with an immuno-privileged site (e.g., primary central nervous system lymphoma, primary testicular lymphoma, primary vitreoretinal lymphoma).
• Absence of mandatory blood sampling for the analysis of circulating tumor DNA (ctDNA) during screening (pre-therapeutic sampling).
• Absence of 18F-FDG PET examination performed within 2 months ≤ the date of signing the consent (mandatory pre-therapeutic PET imaging).
• Pregnant, intending to be pregnant, or breastfeeding woman of childbearing potential

Where it is running

• 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

Full record on ClinicalTrials.gov

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