Kinetics of Circulating Tumor DNA in Lymphoma Treated by Immuno-chemotherapy (LYMPHO-CLEAR)

December 29, 2025 updated by: Centre Henri Becquerel

Prospective Study of Circulating Tumor DNA Kinetics Post R-CHOP Type Treatment of Diffuse Large B Cell Lymphoma

The purpose of this study is to determine the kinetics of circulating tumor DNA (ctDNA) in the hours following initial administration of immuno-chemotherapy to patients with diffuse large B cell lymphoma (DLBCL). Modelizing the short-term kinetics of ctDNA would help to determine the optimal time-point for ctDNA follow-up. The investigators hypothesize that the greater ctDNA release at this time-point compared to baseline might lead lead to the detection of novel variants compared to baseline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ctDNA in diffuse large B cell lymphoma (DLBCL) has become an essential dynamic biomarker. Due to its short half-life, ctDNA is a real-time reflection of tumoral evolution and is a non-invasive biomarker that can be used for patient evaluation and follow-up. The quantity of ctDNA before treatment is correlated with tumoral mass, international prognostic index (IPI) and prognosis. The principal mechanism of ctDNA release is tumor cell apoptosis and it is well established that tumor cell apoptosis is observed in the hours following immuno-chemotherapy. However, the kinetics of ctDNA concentration in the hours following immuno-chemotherapy administration is unknown.

Modelizing the kinetics of ctDNA during this early timeframe could help to better predict chemo-sensitivity and better reflect genetic heterogeneity of the tumor, through release of a larger quantity of ctDNA compared to baseline.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76000
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • Diffuse Large B Cell Lymphoma
  • TEP-TDM at diagnosis
  • Inform Consent form signed
  • Performance status 0 or 1
  • Hospitalized on clinician decision for first cycle of R-CHOP or R-miniCHOP

Exclusion Criteria:

  • Histology other than Diffuse Large B Cell
  • Patient under guardianship or curatorship
  • Incapacity to understand the study or conform to the constraints of the study (language barrier, psychological barrier, geographic barrier…)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Kinetics of circulating tumor DNA
Other: Measure of the circulating tumor DNA
Blood assessment to measure the kinetics au circulating tumor DNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of circulating tumor DNA kinetics
Time Frame: 21 days
Blood assessment to measure circulating tumor concentration
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between circulating tumor DNA concentration and metabolic volume
Time Frame: 6 months
comparison between circulating tumoral concentration and metabolic volume measured on TEP
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Henri Becquerel

Investigators

  • Principal Investigator: Fabrice Jardin, MD,PhD, Centre Henri Becquerel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Actual)

November 4, 2024

Study Completion (Actual)

April 10, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHB23.05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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