Clinical trial NCT04696692: Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma
Official title: Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diffuse Large B-cell Lymphoma
Keywords: Diffuse large B-cell lymphoma
R-CHOP treatment
Biomarker
Single-cell sequencing
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2021-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Levels of ctDNA to determine if it reflect the disease evolution of patient with DLBCL treated in first line.
timeFrame: 24 months for each patient
measure: Levels of tumor tissue biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line.
timeFrame: 24 months for each patient
measure: Levels of blood biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line.
timeFrame: 24 months for each patient
Secondary outcomes:
measure: Levels of tumor tissue biomarkers compared to clinical data in the prediction of treatment response.
timeFrame: 24 months for each patient
measure: Levels of blood biomarkers compared to clinical data in the prediction of treatment response.
timeFrame: 24 months for each patient
measure: Levels of ctDNA compared to conventional PET imaging (at the standard time points) in the prediction of treatment response.
timeFrame: 24 months for each patient
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Institut Universitaire du Cancer Toulouse - Oncopole
Study officials:
References: