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

Not Applicable

Recruiting

• Conditions: Diffuse Large B-Cell Lymphoma; Follicular Lymphoma
• Interventions: Biological: blood sampling

• Registration Number: NCT06813573
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-30
• Study First Submitted: 2025-01-22
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07
• Primary Completion: 2028-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving first line of treatment with a RCHOP 21 regimen	blood sampling	All patients will receive first line of treatment with a RCHOP 21 regimen

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)	We would like to understand whether the more nucleosomes circulating, the more the patient responds to treatment.
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)

Trial Locations

Locations (1)

Gustave Roussy; 🇫🇷 Villejuif, France