Proof of Concept for Real-time Multicentric Monitoring of MRD by PET and ctDNA in Aggressive B-Ce… (NCT07514715) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Proof of Concept for Real-time Multicentric Monitoring of MRD by PET and ctDNA in Aggressive B-Cell Lymphomas
France129 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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Inclusion criteria
✓. Participant, or the participant's legal representative, who voluntarily understands and signs an informed consent form prior to any study specific assessment or procedure.
✓. Aged 12 years or older at the time of signing the informed consent form (ICF), with no upper age limit.
✓. Histologically confirmed diagnosis, according to the 2022 WHO classification, of one of the following lymphomas:
✓. With MYC and BCL2 and/or BCL6 rearrangements (double hit/triple hit)
✓. Not otherwise specified (i.e., without double/triple rearrangements)
✓. Transformed follicular lymphoma (tFL)
✓. Transformed marginal zone lymphoma (tMZL)
✓. Transformed nodal or splenic B cell lymphomas, not otherwise specified (NOS)
Exclusion criteria
✕. Prior systemic anticancer treatment for the current lymphoma before study inclusion. All participants must be treatment naïve for the current lymphoma.
✕. Lymphomas arising in immunoprivileged sites (e.g., primary central nervous system lymphoma, primary testicular lymphoma, primary vitreoretinal lymphoma).
✕. Absence of the mandatory blood sample for circulating tumor DNA (ctDNA) analysis during screening (pre treatment blood sample).
✕
What they're measuring
1
The primary endpoint is the proportion of participants for whom MRD results are delivered within these timelines at the predefined interim treatment response assessment.
Timeframe: at interim timepoint, after Cycle 4 (each cycle is 14 or 21 days)
Trial details
NCT IDNCT07514715
SponsorThe Lymphoma Academic Research Organisation
. Absence of a pre treatment 18F FDG PET scan performed within ≤ 2 months prior to signing the informed consent form (mandatory PET imaging requirement).
✕. Pregnant, breastfeeding, or intending to become pregnant women of childbearing potential.
✕. Any significant medical condition, laboratory abnormality, or psychiatric disorder that may interfere with participation in this clinical study (as judged by the investigator).
✕. Individuals deprived of liberty by judicial or administrative decision.
✕. Individuals hospitalized without their consent.