Clinical trial · Interventional
Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With CAR-T Cells
Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With Anti-CD19 CAR-T Cells for Relapsed or Refractory Diffuse Large B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cells monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Minimal residual disease assessment
- interventionNames
- Other: CAR-T cells monitoring
Primary outcomes (1)
- measure
- Time required to report minimal residual disease report
- timeFrame
- 28 days
- description
- 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.
Secondary outcomes (2)
- measure
- Progression free survival
- timeFrame
- one year
- description
- time between inclusion and progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available