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

NCT06813573 | Recruiting

• 2 other identifiers: 2023-A02716-392023-3670
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Follicular Lymphoma; Diffuse Large B-Cell Lymphoma

Outcome Measures

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)

  From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)

Secondary Outcomes (2)

• Correlation between the level of circulating nucleosomes (number of cells) and the response to treatment as defined by international response criteria

  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

  From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)

Study Arms (1)

Patients receiving first line of treatment with a RCHOP 21 regimen

EXPERIMENTAL

All patients will receive first line of treatment with a RCHOP 21 regimen

Biological: blood sampling

Interventions

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

Patients receiving first line of treatment with a RCHOP 21 regimen

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

David GHEZ

CONTACT

+33 1 42 11 42 40; david.ghez@gustaveroussy.fr

Christophe MARZAC

CONTACT

+33 1 42 11 51 31; christophe.marzac@gustaveroussy.fr

Study Design

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

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 7, 2025
• Study Start: September 30, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)