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

November 7, 2023 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Toulouse, France, 31059
        • Institut Universitaire du Cancer Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: 24 months for each patient
Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS.
24 months for each patient
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.
24 months for each patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months for each patient
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.
24 months for each patient
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
24 months for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2021

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Estimated)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20 HEMA 10

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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