Ireland
--:--IST
Active, not recruiting Not applicable

Study of the Clearance of Minimal Residual Disease Measured at the End of First-line Treatment in Patients With Lymphoma

NCT06744075 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-12-24
Last updated
2025-12-30

Condition(s) studied

B-cell LymphomaHodgkin Lymphoma

Investigational drug(s) / intervention(s)

Blood assessment

Blood assessment: ctDNA collection (venous blood draw) will occur at baseline, mid-treatment, and at the end of treatment

Study summary

This study aims to assess the feasibility of predicting patient outcomes at 1 year and 2 years after the end of first-line treatment using "liquid biopsy" (monitoring of circulating tumor DNA, ctDNA), compared to the currently recommended examination, which is Positon Emission Tomography (PET-CT) imaging at the end of first-line treatment (assessment of therapeutic response using the Deauville score according to the Lugano 2014 criteria). The study will focus on demonstrating the ability of ctDNA clearance to predict 1-year and 2-year outcomes (lymphoma progression or death) in patients treated with first-line therapy for B-cell lymphoma or Hodgkin lymphoma. This could contribute to establishing minimal residual disease clearance as a key endpoint for evaluating the efficacy of therapeutic strategies in future clinical trials and guiding patient management (e.g., de-escalation or intensification strategies, redirection toward immunotherapy, and theranostic approaches).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient aged 18 years or older * Diagnosed with large B-cell lymphoma (including T-cell/histiocyte-rich B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma), follicular B-cell lymphoma (all grades), mantle cell lymphoma (all variants), marginal zone B-cell lymphoma, or Hodgkin lymphoma (classical Hodgkin lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma) * Indication for first-line systemic treatment with chemotherapy or chemoimmunotherapy * Has signed the study-specific informed consent form * Pre-treatment PET-CT scan performed * Patient is affiliated with or a beneficiary of a health insurance plan Exclusion Criteria: * Pregnant or breastfeeding woman * Patient who has already started first-line chemotherapy or chemoimmunotherapy for lymphoma treatment (prephase corticosteroid therapy is allowed) * Patient enrolled in a clinical trial evaluating an early-phase therapeutic agent (Phase I-II) * Patient weighing less than 30 kg * Adult under legal protection measures * Patient unable to understand the study for any reason or unable to comply with the trial requirements (e.g., language barrier, psychological, or geographic issues).

Primary outcome measure(s)

  • Evaluation of the diagnostic performance of minimal residual disease (MRD) at the end of treatment in terms of sensitivity, specificity, positive predictive value, and negative predictive value for predicting 1-year progression-free survival (PFS). — 1 year
    Comparison with the diagnostic performance of PET-CT imaging at the end of first-line treatment for predicting 1-year PFS

Trial sites (2)

FacilityCityRegionStatus
Hôpital Jacques Monod Montivilliers France
Centre Henri Becquerel Rouen France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06744075 on ClinicalTrials.gov ↗ ← All trials in France