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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Recruiting

CT.gov ID

NCT04696692

Collaborator

AstraZeneca (Industry)

Enrollment

Location

Arm

47.7

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-cell Lymphoma	Other: Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 9, 2021

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Patient with histologically confirmed diffuse large B-cell lymphoma	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.

Arm

Intervention/Treatment

Other: Patient with histologically confirmed diffuse large B-cell lymphoma

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.

Outcome Measures

Primary Outcome Measures

Levels of ctDNA to determine if it reflect the disease evolution of patient with DLBCL treated in first line. [24 months for each patient]
Levels of tumor tissue biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line. [24 months for each patient]
Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS.
Levels of blood biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line. [24 months for each patient]
Blood biomarkers will be identified by ScRNA sequencing.

Secondary Outcome Measures

Levels of tumor tissue biomarkers compared to clinical data in the prediction of treatment response. [24 months for each patient]
Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS.
Levels of blood biomarkers compared to clinical data in the prediction of treatment response. [24 months for each patient]
Blood biomarkers will be identified by ScRNA sequencing.
Levels of ctDNA compared to conventional PET imaging (at the standard time points) in the prediction of treatment response. [24 months for each patient]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)
Age 18 to 80 years at the time of study entry
Archived initial diagnostic tumor specimen available
Life expectancy ≥ 3months
ECOG Performance status 0-2
FDG-avid disease (for PET monitoring)
Signed written informed consent
Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
Patient affiliated to a Social Health Insurance in France

Exclusion Criteria:

Patient pregnant, or breast-feeding
Any condition contraindicated with tumor / blood sampling procedures required by the protocol
Central Nervous System (CNS) involvement
Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders
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
Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Current participation in any other therapeutic clinical study