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NCT Number: NCT06813573

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

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.

Recruiting

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Key information

Conditions

Follicular Lymphoma Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy

Villejuif, 94800, France

Location status: Recruiting

Location contact

Christophe MARZAC

SUB_INVESTIGATOR

David GHEZ

CONTACT

[email protected]

+33 1 42 11 42 40

David GHEZ

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling

Biological

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe MARZAC

CONTACT

[email protected]

+33 1 42 11 51 31

David GHEZ

CONTACT

[email protected]

+33 1 42 11 42 40

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Registry information

Acronym: EVOLITION

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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