- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05675982
Real-Time Monitoring of Circulating Tumor DNA and Study of Prognostic Factors in Patients Treated With CAR-T Cells (RT-CAR)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main objective is to demonstrate the feasibility of monitoring residual disease in real time by monitoring circulating tumor DNA in patients with relapsed or refractory diffuse large cell B-cell lymphoma treated with anti-CD19 CAR-T (axi-cel, tisa -cel or liso-cel).
The primary endpoint of the study is to assess the capacity of our research lab to transmit the result of the molecular characterization of the residual disease (MRD) sampled on Day+7 (+/- 3 days) of the injection of CAR-Ts (MRD evaluated by the quantity of ctDNA by NGS technique) of the patient with DLBCL R/R treated with CAR-T, to the recruiting investigator no later than Day+28 (+ /- 3 days). We will evaluate the proportion between the number of informative evaluable patients (patients with at least one detectable mutation in pre-treatment and having reached the PET-CT evaluation of Day+28) and the total number of informative patients (patients with at least one mutation detectable in pre-treatment). The target will be achieved and real-time MRD assessment will be considered feasible if the proportion is at least 80%.
Patients who do not have a detectable mutation in pre-treatment ("non-informative patients for follow-up of residual disease"), as well as patients who do not reach the ctDNA sample by Day+7, and/or do not not reaching the PET-CT by Day+28, will be considered as not evaluable for the primary endpoint, and will be the subject of a separate descriptive analysis and will be evaluable for the secondary objectives. We took this into account when evaluating the number of patients to include.
Day0 corresponds to the day of injection of the CAR-Ts, Day+7 corresponds to the 8th day post-injection of the CAR-Ts, and D+28 refers to the planned date of the PET-CT evaluation of Day+28 (this examination being the "gold standard" for the evaluation of the response to treatment with CAR-T).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vincent Camus, MD
- Phone Number: +33232082222
- Email: vincent.camus@chb.unicancer.fr
Study Locations
-
-
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Rouen, France
- Centre Henri Becquerel
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Contact:
- Vincent Camus, MD
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Contact:
- Doriane Richard, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Minimal residual disease assessment
|
monitoring of circulating DNA by blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time required to report minimal residual disease report
Time Frame: 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.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: one year
|
time between inclusion and progression
|
one year
|
Overall survival
Time Frame: one year
|
time between inclusion and death with all cause of mortality
|
one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent Camus, MD, Centre Henri Becquerel
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHB22.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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