Follicular LymphomaEVOLITIONNCT06813573
Prospective Analysis of Circulating Nucleosomes in Patients Receiving a First Line Treatment for a Non-Hodgkin Lymphoma
A study testing blood sampling in people with Follicular Lymphoma and Diffuse Large B-Cell Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
The goal of this study is to prospectively follow the level of circulating nucleosomes in patients treated for a non-Hodgkin lymphoma and determine whether it correlates with the clinical response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
- What is being tested?
- blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2024to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven diagnosis of diffuse large B cell lymphoma or follicular lymphoma, according to the WHO 2016 classification, requiring a first line of treatment with a RCHOP 21 regimen
- Agreement to participate after receiving oral and written information on the study
Who cannot join
- History of previous treatment for lymphoma (excluding localized low dose radiotherapy in the case of follicular lymphoma)
- Treatment with a chemotherapy regimen different from RCHOP21
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to prospectively follow the level of circulating nucleosomes in patients treated for a non-Hodgkin lymphoma and determine whether it correlates with the clinical response.
- Conditions
- Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
- Being tested
- blood sampling
- Medical subject headings
- Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
A maximum of 4 tubes of 10ml will be collected: at baseline (before cycle 1), before each cycle (from 2 to 6 included), at the end of the treatment, and in case of relapse during follow-up period
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving first line of treatment with a RCHOP 21 regimen | Experimental | All patients will receive first line of treatment with a RCHOP 21 regimen Receives: Biological: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective quantitative analysis of the level of circulating nucleosomes at baseline and during treatment in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL)
Measured: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)
Secondary outcomes (2)
Correlation between the level of circulating nucleosomes (number of cells) and the response to treatment as defined by international response criteria
We would like to understand whether the more nucleosomes circulating, the more the patient responds to treatment.
Measured: From enrollment to the end of the treatment (6 cycles of 21 days)
Comparison between the results of molecular analysis of ctDNA and DNA extracted from nucleosomes
Measured: From enrollment to the end of the study (24 months of follow-up from beginning of treatment 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 posted7 Feb 2025
- Study start30 Sep 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813573
- Sponsor's protocol ID
- 2023-A02716-39
- Other IDs
- 2023-3670
- Acronym
- EVOLITION
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Circulating Nucleosomes in Patients Receiving a First Line Treatment for a Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT06813573
- Acronym / sponsor ID
- EVOLITION / 2023-A02716-39
- Conditions
- Follicular Lymphoma, Diffuse Large B-Cell Lymphoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 7 Feb 2025 (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.
The goal of this study is to prospectively follow the level of circulating nucleosomes in patients treated for a non-Hodgkin lymphoma and determine whether it correlates with the clinical response.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving first line of treatment with a RCHOP 21 regimen | Experimental | Biological: blood samplingAll patients will receive first line of treatment with a RCHOP 21 regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically proven diagnosis of diffuse large B cell lymphoma or follicular lymphoma, according to the WHO 2016 classification, requiring a first line of treatment with a RCHOP 21 regimen
- Agreement to participate after receiving oral and written information on the study
Key exclusion criteria (2 listed)
- History of previous treatment for lymphoma (excluding localized low dose radiotherapy in the case of follicular lymphoma)
- Treatment with a chemotherapy regimen different from RCHOP21
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 |
|---|---|---|
| blood samplingA maximum of 4 tubes of 10ml will be collected: at baseline (before cycle 1), before each cycle (from 2 to 6 included), at the end of the treatment, and in case of relapse during follow-up period | Biological | Patients receiving first line of treatment with a RCHOP 21 regimen |
Primary outcome
Prospective quantitative analysis of the level of circulating nucleosomes at baseline and during treatment in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL)
Time frame: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)
2 secondary outcomes
Correlation between the level of circulating nucleosomes (number of cells) and the response to treatment as defined by international response criteria
Time frame: From enrollment to the end of the treatment (6 cycles of 21 days)
Comparison between the results of molecular analysis of ctDNA and DNA extracted from nucleosomes
Time frame: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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 blood sampling in people with Follicular Lymphoma and Diffuse Large B-Cell Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Prospective quantitative analysis of the level of circulating nucleosomes at baseline and during treatment in patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (time frame: From enrollment to the end of the study (24 months of follow-up from beginning of treatment for each patient)). 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 5 Oct 2026.