Using circulating tumor DNA to predict treatment response in lymphoma patients
Official title: Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)
Run by Centre Henri Becquerel · NCT04824950 · Data updated 2026-11-12
This study is testing if checking blood for tumor DNA can better predict how well lymphoma patients will respond to chemotherapy compared to traditional scans after their first two treatments.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 87 (estimated) |
| Sponsor | Centre Henri Becquerel Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Lyon and 1 other locations) |
| Status | Recruiting |
| Started | March 22, 2021 |
| Main results expected | March 1, 2028 |
| Study ends | March 1, 2028 |
| Registry record updated | April 1, 2021 |
| Trial ID | NCT04824950 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old with newly diagnosed primary mediastinal large B-cell lymphoma who have not yet started chemotherapy.
✕Probably not a fit
Patients who have already begun chemotherapy or have contraindications to PET-CT will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of circulating tumor DNA (ctDNA) monitoring compared to positron emission tomography-computed tomography (PET-CT) in predicting treatment responses in patients with primary mediastinal large B-cell lymphoma (PMBL) after two cycles of chemotherapy. By utilizing next-generation sequencing (NGS), the study seeks to identify patients who may not respond to standard chemotherapy regimens early in their treatment. The goal is to improve patient outcomes by allowing for more personalized treatment strategies based on the detection of minimal residual disease. This multicenter pilot project will provide valuable insights into the evolution of tumor clones during treatment.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate predictions of treatment response, allowing for timely adjustments in therapy for patients with PMBL.
How similar studies have gone: While there have been studies on minimal residual disease in other types of lymphomas, this specific approach using ctDNA in PMBL is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient over 18 years of age, * Suffering from a diffuse primary B lymphoma of the mediastinum, newly diagnosed locally on a biopsy with anatomopathological analysis according to the recommendations of the WHO 2016 classification of hematological malignancies, * All stages (I-IV) * All IPI scores (0-5) * With mediastinal involvement, * Untreated (apart from emergency corticosteroid therapy less than 2mg/kg/day for 7 days), * Treatment with R-CHOP-14 or R-ACVBP with PET-CT guided strategy (delta SUVmax) to be initiated, * Tumor fixation above liver background on pre-treatment FDG PET/CT/CT (Deauville score ≥4), * Having signed the informed consent prior to any study procedure * Affiliated or beneficiary of a social protection plan. Exclusion Criteria: * Patient who has already started chemotherapy treatment, * Contraindication to FDG PET-CT, * No mediastinal involvement, * Positive HIV serology, * Positive hepatitis B or C serology with positive viral load, * Protected adult (under guardianship or curatorship), * Pregnant or breastfeeding women, * Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
Where it's running
-
Centre Henri Becquerel
Rouen, France Recruiting -
Centre Hospitalier Lyon Sud
Lyon, France Not yet recruiting
Study contacts
- Principal investigator: Vincent Camus, Md — Centre Henri Becquerel
- Study coordinator: Vincent Camus, Md
- Email: vincent.camus@chb.unicancer.fr
- Phone: +33232082497
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.