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

NCT04696692 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Institut Claudius Regaud

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2025-12-11
Completion
2025-12-11

Countries

  • France

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04696692 on ClinicalTrials.gov