Prospective Analysis of Circulating Nucleosomes in Patients Receiving a First Line Treatment for a Non-Hodgkin Lymphoma (EVOLITION)

February 3, 2025 updated by: Gustave Roussy, Cancer Campus, Grand Paris
The goal of this study is to prospectively follow the level of circulating nucleosomes in patients treated for a non-Hodgkin lymphoma and determine whether it correlates with the clinical response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact

Study Contact Backup

Study Locations

  • France
      • Villejuif, France, 94800
        • Recruiting
        • Gustave Roussy
        • Contact:
        • Principal Investigator:
          • David GHEZ
        • Sub-Investigator:
          • Christophe MARZAC

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:

  • Histologically proven diagnosis of diffuse large B cell lymphoma or follicular lymphoma, according to the WHO 2016 classification, requiring a first line of treatment with a RCHOP 21 regimen
  • Agreement to participate after receiving oral and written information on the study

Exclusion Criteria:

  • History of previous treatment for lymphoma (excluding localized low dose radiotherapy in the case of follicular lymphoma)
  • Treatment with a chemotherapy regimen different from RCHOP21

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: Patients receiving first line of treatment with a RCHOP 21 regimen
All patients will receive first line of treatment with a RCHOP 21 regimen
Biological: blood sampling
A maximum of 4 tubes of 10ml will be collected: at baseline (before cycle 1), before each cycle (from 2 to 6 included), at the end of the treatment, and in case of relapse during follow-up period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prospective quantitative analysis of the level of circulating nucleosomes at baseline and during treatment in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL)
Time Frame: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)
From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between the level of circulating nucleosomes (number of cells) and the response to treatment as defined by international response criteria
Time Frame: From enrollment to the end of the treatment (6 cycles of 21 days)
We would like to understand whether the more nucleosomes circulating, the more the patient responds to treatment.
From enrollment to the end of the treatment (6 cycles of 21 days)
Comparison between the results of molecular analysis of ctDNA and DNA extracted from nucleosomes
Time Frame: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)
From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)

Collaborators and Investigators

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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

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)

September 30, 2024

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2029

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A02716-39
  • 2023-3670 (Other Identifier: CSET number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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