Diffuse Large B Cell Lymphoma (DLBCL)CHARTHERNCT07181785
Molecular Characterization and Outcomes of Aggressive B-Cell Lymphomas.
An observational study of Diffuse Large B Cell Lymphoma (DLBCL), run by Andrés José Maria Ferreri at 1 site in Italy.
Trial summary
This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, single-center series of large B-cell lymphomas, in order to allow a better classifications of these cases according to the current WHO 2017 classification. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma (DLBCL)
- What is being tested?
- Treatments: anthracycline-based combinations followed or not by involved-field radiotherapy
- How many people
- 555 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jul 2022to 12 Jul 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphomas
Who may be able to join
None listed.
Who cannot join
- Histologic diagnosis other than DLBCL or unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Retrospective Study Aimed to Perform a Molecular Characterization of Aggressive B-cell Lymphomas (Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma With MYC and BCL2 and/or BCL6 Translocations, High-grade B-cell Lymphoma Not Otherwise Specified) and to Observe the Clinical Patients' Outcomes According to the 2017 WHO Classification
This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, single-center series of large B-cell lymphomas, in order to allow a better classifications of these cases according to the current WHO 2017 classification. If this evaluation will be confirmed as a reliable method to reclassify in different groups the evaluated tumors, it can be subsequently routinely apply to indicate the best treatment approaches in this high-risk setting of patients with a significant impact on patients' morbidity and mortality, and also on the health system and related costs.
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Being tested
- Treatments: anthracycline-based combinations followed or not by involved-field radiotherapy
- 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.
Treatments: anthracycline-based combinations followed or not by involved-field radiotherapyCombination product
Anthracycline-based combinations followed or not by involved-field radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphoma. | Histologically-confirmed diagnosis of LBCL (i.e., DLBCL, HGBCL, unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL), or aggressive B-cell lymphomas with blastoid morphology (excluding blastoid variant of mantle cell lymphoma and lymphoblastic lymphoma)
* Histopathological diagnosis performed between 2000 and 2019.
* HIV sero-negativity
* Age ≥18
* Treatment with R-CHOP or other intensified polychemotherapy regimen
* Availability of adequate histopathological samples at diagnosis for FISH analysis
* Availability of clinical records and outcomes data Receives: Combination Product: Treatments: anthracycline-based combinations followed or not by involved-field radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival (OS) is time from the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first.
Measured: From the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months
Secondary outcomes (6)
Progression-free Survival (PFS)
Progression-Free Survival (PFS) is the length of time during and after a disease treatment that a patient lives without the disease worsening or progressing
Measured: From the first day of treatment until relapse, progression, death , or last follow-up, whichever occurs first, assessed up to 60 months
Overall Response Rate
the Overall Response Rate (ORR) measures the percentage of patients whose disease shows a reduction in size or is eliminated after a specific treatment. It includes patients who achieve either a Complete Response (CR), where all signs of the lymphoma disappear, or a Partial Response (PR), where there is a significant reduction in tumor burden but some signs of the disease remain
Measured: From the first day of treatment until the date of first documented response assessment, typically within 6 months of treatment initiation
Duration of response (DOR; partial response [PR] + complete remission [CR])
Time from the date of first documented response (complete or partial) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first.
Measured: From the date of first documented response (CR or PR) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months
Relapse rates
Proportion of patients who experience disease relapse after achieving a complete or partial response.
Measured: From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months
Relapse Pattern
Description of the type and location of disease relapse, including nodal vs extranodal and local vs systemic recurrence
Measured: From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months
Incidence of chromosomal rearrangements involving MYC gene and BCL2 gene (so called "double hit lymphoma", representing 60% of HGBL) and/or BCL6 (also called "triple hit lymphoma", representing 20% of HG in Large B-cell Lymphomas.
Proportion of patients with documented genetic rearrangements of MYC, BCL2, or BCL6 detected at the time of pathologic diagnosis.
Measured: At the time of pathologic diagnosis (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start12 Jul 2022
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Large B Cell Lymphoma (DLBCL)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrés José Maria Ferreri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrés José Maria Ferreri, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181785
- Sponsor's protocol ID
- CHARTHER
- Acronym
- CHARTHER
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferreri AJM, Erbella F, Angelillo P, Pecciarini L, Bongiovanni L, Nonis A, Cangi MG, Ponti MV, Saliani L, Fiore P, Bruno-Ventre M, Girlanda S, Marino F, Flospergher E, Cassanello G, Palumbo F, Calimeri T, Ponzoni M. Three-Hour Infusion of Methotrexate at 3 g/m2 With or Without Intrathecal Chemotherapy Significantly Reduces CNS Relapses and Improves Survival in Patients With Large B-Cell Lymphomas at Increased CNS Risk. Am J Hematol. 2026 Jun;101(6):1244-1254. doi: 10.1002/ajh.70283. Epub 2026 Mar 15.
PubMed 41832699
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Retrospective Study Aimed to Perform a Molecular Characterization of Aggressive B-cell Lymphomas (Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma With MYC and BCL2 and/or BCL6 Translocations, High-grade B-cell Lymphoma Not Otherwise Specified) and to Observe the Clinical Patients' Outcomes According to the 2017 WHO Classification
- ClinicalTrials.gov ID
- NCT07181785
- Acronym / sponsor ID
- CHARTHER / CHARTHER
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Andrés José Maria FerreriUniversity, hospital or other
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 18 Sep 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.
This is a retrospective analysis of the presence of chromosomal rearrangements involving MYC, BCL2 and BCL6 genes by FISH in a retrospective, single-center series of large B-cell lymphomas, in order to allow a better classifications of these cases according to the current WHO 2017 classification. If this evaluation will be confirmed as a reliable method to reclassify in different groups the evaluated tumors, it can be subsequently routinely apply to indicate the best treatment approaches in this high-risk setting of patients with a significant impact on patients' morbidity and mortality, and also on the health system and related costs.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphoma. | – | Combination Product: Treatments: anthracycline-based combinations followed or not by involved-field radiotherapyHistologically-confirmed diagnosis of LBCL (i.e., DLBCL, HGBCL, unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL), or aggressive B-cell lymphomas with blastoid morphology (excluding blastoid variant of mantle cell lymphoma and lymphoblastic lymphoma) * Histopathological diagnosis performed between 2000 and 2019. * HIV sero-negativity * Age ≥18 * Treatment with R-CHOP or other intensified polychemotherapy regimen * Availability of adequate histopathological samples at diagnosis for FISH analysis * Availability of clinical records and outcomes data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphomas
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Histologic diagnosis other than DLBCL or unclassifiable B-cell lymphoma with features intermediate between DLBCL and BL
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 |
|---|---|---|
| Treatments: anthracycline-based combinations followed or not by involved-field radiotherapyAnthracycline-based combinations followed or not by involved-field radiotherapy | Combination product | Adult subjects (> 18 years old) of any age and gender affected by large B-cell lymphoma. |
Primary outcome
Overall Survival (OS)
Time frame: From the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months
Overall survival (OS) is time from the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first.
6 secondary outcomes
Progression-free Survival (PFS)
Time frame: From the first day of treatment until relapse, progression, death , or last follow-up, whichever occurs first, assessed up to 60 months
Overall Response Rate
Time frame: From the first day of treatment until the date of first documented response assessment, typically within 6 months of treatment initiation
Duration of response (DOR; partial response [PR] + complete remission [CR])
Time frame: From the date of first documented response (CR or PR) until disease progression, relapse, death from any cause, or last follow-up, whichever occurs first, assessed up to 60 months
Relapse rates
Time frame: From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months
Relapse Pattern
Time frame: From the date of first documented response (CR or PR) until disease relapse or last follow-up, whichever occurs first, assessed up to 60 months
Incidence of chromosomal rearrangements involving MYC gene and BCL2 gene (so called "double hit lymphoma", representing 60% of HGBL) and/or BCL6 (also called "triple hit lymphoma", representing 20% of HG in Large B-cell Lymphomas.
Time frame: At the time of pathologic diagnosis (baseline)
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 18 Sep 2025.
- Derived from this study: PubMed 41832699Ferreri AJM, Erbella F, Angelillo P, Pecciarini L, Bongiovanni L, Nonis A, Cangi MG, Ponti MV, Saliani L, Fiore P, Bruno-Ventre M, Girlanda S, Marino F, Flospergher E, Cassanello G, Palumbo F, Calimeri T, Ponzoni M. Three-Hour Infusion of Methotrexate at 3 g/m2 With or Without Intrathecal Chemotherapy Significantly Reduces CNS Relapses and Improves Survival in Patients With Large B-Cell Lymphomas at Increased CNS Risk. Am J Hematol. 2026 Jun;101(6):1244-1254. doi: 10.1002/ajh.70283. Epub 2026 Mar 15.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Diffuse Large B Cell Lymphoma (DLBCL), run by Andrés José Maria Ferreri at 1 site in Italy.
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 0 inclusion and 1 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 18 Sep 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 Italy. 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?
Overall Survival (OS) (time frame: From the date of pathologic diagnosis until death from any cause or last follow-up, whichever occurs first, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07181785, which also lists 1 linked publication.
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 18 Sep 2025.