NCT04696692

Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is a translational, prospective, open-label, monocentric research. The study will be conducted in a population of 60 patients with diffuse large B-cell lymphoma (DLBCL) for whom first-line treatment with R-CHOP is planned as part of their standard of care. SIMILY program aims at identifying biomarkers and/or molecular signatures related to immuno-phenotypic and -genotypic characteristics of the tumor and immune microenvironment, at the time of diagnosis, during R-CHOP, and at 24 months or time of progression. Each patient will be followed during 2 years.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
OTHER	Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.	Blood samples will be collected : * at baseline (before the 1st R-CHOP cycle) * before the 3d administration of chemotherapy (CT) (i.e. after 2 cycles of CT and same timepoint as interim FDG-PET/CT) * after the 4th administration of the CT * at the end of induction (i.e. end of R-CHOP treatment) * at 24 months after initiation of R-CHOP treatment * at the time of progression (if progression occurs before 24 months of treatment). Tumor samples will be collected at baseline (from an archived initial diagnostic tumor specimen) and at the time of progression (if applicable from lymph node biopsy performed as part of a standard of care surgical procedure). Bone marrow samples will be collected at baseline and at the time of progression (if applicable) only in patients for whom a bone marrow aspiration (BMA) is necessary as part of their standard of care, upon physician's decision.

Timeline

• Start date: 2021-02-09
• Primary completion: 2025-12-11
• Completion: 2025-12-11
• First posted: 2021-01-06
• Last updated: 2025-12-22

Locations

1 site across 1 country: France