search
Back to results

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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diffuse Large B-cell Lymphoma focused on measuring Diffuse large B-cell lymphoma, R-CHOP treatment, Biomarker, Single-cell sequencing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Institut Universitaire du Cancer Toulouse - OncopoleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patient with histologically confirmed diffuse large B-cell lymphoma

Arm Description

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 4, 2021
Last Updated
March 29, 2023
Sponsor
Institut Claudius Regaud
Collaborators
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT04696692
Brief Title
Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma
Acronym
SIMILY
Official Title
Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-cell Lymphoma
Keywords
Diffuse large B-cell lymphoma, R-CHOP treatment, Biomarker, Single-cell sequencing

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with histologically confirmed diffuse large B-cell lymphoma
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.
Intervention Description
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 Outcome Measure Information:
Title
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
Title
Levels of tumor tissue biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line.
Description
Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS.
Time Frame
24 months for each patient
Title
Levels of blood biomarkers to determine if it reflect the disease evolution of patient with DLBCL treated in first line.
Description
Blood biomarkers will be identified by ScRNA sequencing.
Time Frame
24 months for each patient
Secondary Outcome Measure Information:
Title
Levels of tumor tissue biomarkers compared to clinical data in the prediction of treatment response.
Description
Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS.
Time Frame
24 months for each patient
Title
Levels of blood biomarkers compared to clinical data in the prediction of treatment response.
Description
Blood biomarkers will be identified by ScRNA sequencing.
Time Frame
24 months for each patient
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loïc YSEBAERT
Phone
+33 (0)5 31 15 63 51
Email
ysebaert.loic@iuct-oncopole.fr
Facility Information:
Facility Name
Institut Universitaire du Cancer Toulouse - Oncopole
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Loïc YSEBAERT
Phone
+33 (0)5 31 15 63 51
Email
ysebaert.loic@iuct-oncopole.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs