Diffuse Large B-cell LymphomaSIMILYNCT04696692
Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma
A study testing Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP. in people with Diffuse Large B-cell Lymphoma, run by Institut Claudius Regaud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2021to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, 31059
About this study
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.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.
- Keywords
- Diffuse large B-cell lymphoma, R-CHOP treatment, Biomarker, Single-cell sequencing
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient with histologically confirmed diffuse large B-cell lymphoma | Other | Not described Receives: Other: Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of ctDNA to determine if it reflect the disease evolution of patient with DLBCL treated in first line.
Measured: 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.
Tumor tissue biomarkers will be identified by ScRNA sequencing and targeted NGS.
Measured: 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.
Blood biomarkers will be identified by ScRNA sequencing.
Measured: 24 months for each patient
Secondary outcomes (3)
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.
Measured: 24 months for each patient
Levels of blood biomarkers compared to clinical data in the prediction of treatment response.
Blood biomarkers will be identified by ScRNA sequencing.
Measured: 24 months for each patient
Levels of ctDNA compared to conventional PET imaging (at the standard time points) in the prediction of treatment response.
Measured: 24 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start9 Feb 2021
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696692
- Sponsor's protocol ID
- 20 HEMA 10
- Acronym
- SIMILY
- Status last verified
- Dec 2025
- First submitted
- 4 Jan 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT04696692
- Acronym / sponsor ID
- SIMILY / 20 HEMA 10
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Diffuse large B-cell lymphoma, R-CHOP treatment, Biomarker, Single-cell sequencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with histologically confirmed diffuse large B-cell lymphoma | Other | Other: Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patient with histologically confirmed diffuse large B-cell lymphoma |
Primary outcome
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
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.
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.
3 secondary outcomes
Levels of tumor tissue biomarkers compared to clinical data in the prediction of treatment response.
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP. in people with Diffuse Large B-cell Lymphoma, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.