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Clinical Trials in France / NCT05675982
Active, not recruiting Not applicable

Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With CAR-T Cells

NCT05675982 · tracked via the Priya Life Science France tracker
Sponsor
Centre Henri Becquerel
Phase
Not applicable
Started
2023-01-13
Last updated
2026-01-02

Condition(s) studied

Diffuse Large B Cell Lymphoma

Investigational drug(s) / intervention(s)

CAR-T cells monitoring

CAR-T cells monitoring: monitoring of circulating DNA by blood sample

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients aged 18 or over * Carriers 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/R * Patients with an indication for treatment with CAR-T anti CD19 * PET-CT pre-injection of CAR-T performed * Signed informed consent * Patients affiliated or beneficiaries of a health insurance scheme Exclusion Criteria: * Pregnant or breastfeeding women * Absence or insufficiency of tumor material (patient's most recent diagnostic biopsy) fixed in FFPE paraffin of insufficient quality/quantity for next-generation sequencing (NGS) analysis * Lack of patient consent * Patient treated with CAR-T as part of a therapeutic clinical trial * Patient whose weight is less than 30 kg * Protected 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.).

Primary outcome measure(s)

  • Time required to report minimal residual disease report — 28 days
    To to assess the capacity of the research lab to transmit the result of the molecular characterization of the residual disease sampled on day 7 of the injection of CAR-Ts of the patient to the recruiting investigator no later than day 28.

Trial sites (1)

FacilityCityRegionStatus
Centre Henri Becquerel Rouen France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05675982 on ClinicalTrials.gov ↗ ← All trials in France