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

Institut Claudius Regaud

Status: Completed

Conditions: Diffuse Large B-cell Lymphoma

Treatments: Other: Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04696692

20 HEMA 10

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP (treatment by R-CHOP should not have been initiated prior to inclusion in the study)
2. Age 18 to 80 years at the time of study entry
3. Archived initial diagnostic tumor specimen available
4. Life expectancy ≥ 3months
5. ECOG Performance status 0-2
6. FDG-avid disease (for PET monitoring)
7. Signed written informed consent
8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
9. Patient affiliated to a Social Health Insurance in France

Exclusion criteria

1. Patient pregnant, or breast-feeding
2. Any condition contraindicated with tumor / blood sampling procedures required by the protocol
3. Central Nervous System (CNS) involvement
4. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders
6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
8. Current participation in any other therapeutic clinical study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Patient with histologically confirmed diffuse large B-cell lymphoma

Other group

Treatment:

Other: Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.