Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Conditions
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.
Interventions
BIOLOGICALblood 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
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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) | From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
France
Contacts
Primary ContactDavid GHEZ
Backup ContactChristophe MARZAC
Outcome results
None listed