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

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ClinicalTrials.gov Identifier: NCT04696692
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Institut Claudius Regaud

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. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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)
  • 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 Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04696692


Contacts
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Contact: Loïc YSEBAERT +33 (0)5 31 15 63 51 ysebaert.loic@iuct-oncopole.fr

Locations
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France
Institut Universitaire du Cancer Toulouse - Oncopole Recruiting
Toulouse, France, 31059
Contact: Loïc YSEBAERT    +33 (0)5 31 15 63 51    ysebaert.loic@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud
AstraZeneca
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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT04696692    
Other Study ID Numbers: 20 HEMA 10
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Claudius Regaud:
Diffuse large B-cell lymphoma
R-CHOP treatment
Biomarker
Single-cell sequencing
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases