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NCT05675982
Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With CAR-T Cells
Conditions: Diffuse Large B Cell Lymphoma
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 40
Sponsor: Centre Henri Becquerel
Location: France
Summary
The purpose of this study is to demonstrate that it is possible to report in real time (less than 3 weeks) to the hematologist the results of the molecular minimal residual disease (MRD) based on blood circulating tumor DNA (ctDNA) assessment taken approximately 7 days after the reinjection of the CAR-T cells, in order to be able to anticipate a possible progression of the disease and to be able to propose salvage or earlier adjuvant therapy to improve patient prognosis.
Eligibility Criteria
Inclusion Criteria:Patients aged 18 or overCarriers of relapsed or refractory diffuse large cell B-cell lymphoma (LBDGC R/R), relapsed or refractory primary mediastinum B-cell lymphoma or follicular lymphoma transformed into LBDGC R/RPatients with an indication for treatment with CAR-T anti CD19PET-CT pre-injection of CAR-T performedSigned informed consentPatients affiliated or beneficiaries of a health insurance schemeExclusion Criteria:Pregnant or breastfeeding womenAbsence or insufficiency of tumor material (patient's most recent diagnostic biopsy) fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysisLack of patient consentPatient treated with CAR-T as part of a therapeutic clinical trialPatient whose weight is less than 30 kgProtected adult or deprived of liberty (under guardianship or curatorship)Patient unable to understand the study for any reason whatsoever or to comply with the constraints of the trial (language, psychological, geographic problem, etc.).
Source: ClinicalTrials.gov (NCT05675982). StuddyBuddy aggregates publicly available trial information.