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.
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)
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).
Participants with aggressive B cell lymphoma
Other
Prospective
blood test
Other interventionThree blood tests will be performed (one before treatment, one at mid treatment, and one at the end of treatment) for ctDNA analysis.
The primary endpoint is the proportion of participants for whom MRD results are delivered within these timelines at the predefined interim treatment response assessment.
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.
Survival
Event Free Survival (EFS) by histology subtype
Progression/relapse
Duration of response (DoR) as defined by Lugano 2014 criteria
Evaluate the prognostic value of ctDNA/radiomics PET at mid-treatment and end-of-treatment
PFS according to ctDNA MRD status at the interim assessment and at the end of treatment assessment (positive vs negative), according to the interim PET response (response per Lugano 2014 and other radiomic parameters), and according to their combination (ctDNA + PET).
To document and classify the reasons for unsuccessful PET acquisition, analysis or reporting
Number of participants with delayed results, and reasons associated.
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