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Completed

NCT Number: NCT04696692

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

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.

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut Universitaire du Cancer Toulouse - Oncopole

Toulouse, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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.

Primary outcomes

  1. Levels of ctDNA to determine if it reflect the disease evolution of patient with DLBCL treated in first line.

    Time frame: 24 months for each patient

  2. Levels of tumor tissue biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line.

    Time frame: 24 months for each patient

    Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS.

  3. Levels of blood biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line.

    Time frame: 24 months for each patient

    Blood biomarkers will be identified by ScRNA sequencing.

Secondary outcomes

  1. Levels of tumor tissue biomarkers compared to clinical data in the prediction of treatment response.

    Time frame: 24 months for each patient

    Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS.

  2. Levels of blood biomarkers compared to clinical data in the prediction of treatment response.

    Time frame: 24 months for each patient

    Blood biomarkers will be identified by ScRNA sequencing.

  3. Levels of ctDNA compared to conventional PET imaging (at the standard time points) in the prediction of treatment response.

    Time frame: 24 months for each patient

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Collaborators

  • AstraZeneca

Registry information

Acronym: SIMILY

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2021
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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