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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Lymphoma Academic Research Organisation

About this trial

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 criteria

Qualifiers

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)

Diffuse large B-cell lymphoma, unspecified (DLBCL not specified)

With rearrangements of the MYC and BCL2 and/or BCL6 genes (double/triple hit)

Disqualifiers

Systemic anticancer treatment of current lymphoma prior to inclusion in the study. All participants must be previously untreated for current lymphoma.

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).

Trial design

Treatments tested in this trial

  • blood test

Treatment groups

129 Participants
are divided into 1 treatment group