Recruiting NCT06813573
Prospective Analysis of Circulating Nucleosomes in Patients Receiving a First Line Treatment for a Non-Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: blood sampling.
- Who it may be relevant to
- Registry conditions: Follicular Lymphoma, Diffuse Large B-Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- 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 outcome measures (2)
- 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)]
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Gustave Roussy — Villejuif
Identifiers
NCT: NCT06813573 · 2023-A02716-39 · 2023-3670