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

NCT05675982 | Active Not Recruiting

• 1 other identifier: CHB22.02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diffuse Large B Cell Lymphoma

Keywords

Circulating tumor DNA; Diffuse Large B Cell Lymphoma; next generation sequencing; liquid biopsy

Outcome Measures

Primary Outcomes (1)

• Time required to report minimal residual disease report

  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.

  28 days

Secondary Outcomes (2)

• Progression free survival

  one year

• Overall survival

  one year

Study Arms (1)

Minimal residual disease assessment

EXPERIMENTAL

Other: CAR-T cells monitoring

Interventions

CAR-T cells monitoring OTHER

monitoring of circulating DNA by blood sample

Minimal residual disease assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Vincent Camus, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: January 13, 2023
• Primary Completion: September 8, 2025
• Study Completion (Estimated): September 8, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)