Using circulating tumor DNA to predict treatment response in lymphoma patients

Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 87 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Henri Becquerel (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Lyon and 1 other locations)
• Trial ID: NCT04824950 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients who have already begun chemotherapy or have contraindications to PET-CT will not benefit from this study.

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 performed: 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.

Eligibility 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 this trial is running

Lyon and 1 other locations

• Centre Hospitalier Lyon Sud — Lyon, France (Not_yet_recruiting)
• Centre Henri Becquerel — Rouen, France (Recruiting)

Study contacts

• Principal investigator: Vincent Camus, Md — Centre Henri Becquerel
• Study coordinator: Vincent Camus, Md

Conditions Primary Mediastinal Large B-cell Lymphoma; Circulating tumor DNA; Next Generation sequencing