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

NCT06744075 | Active Not Recruiting

• 1 other identifier: CHB24.02
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

B-cell Lymphoma; Hodgkin Lymphoma

Keywords

Lymphoma; Liquid biopsy; Minimal Residual Disease; Poitron Emission Tomography; Circulating Tumor DNA

Outcome Measures

Primary Outcomes (1)

• 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).

  Comparison with the diagnostic performance of PET-CT imaging at the end of first-line treatment for predicting 1-year PFS

  1 year

Secondary Outcomes (2)

• Response rates

  6 months

• Overall survival

  one year

Study Arms (1)

CELERITY Arm

OTHER

CT DNA Collection at baseline, mid-treatment and at the end of treatment

Other: Blood assessment

Interventions

Blood assessment OTHER

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

CELERITY Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (2)

Hôpital Jacques Monod

Montivilliers, 76290, France

Location

Centre Henri Becquerel

Rouen, 76038, France

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Hodgkin Disease; Lymphoma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: December 24, 2024
• Primary Completion (Estimated): December 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

FR (2)