Diffuse Large B Cell LymphomaFIL_MIMYCNCT06588205
Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma
An observational study of Diffuse Large B Cell Lymphoma and High-grade B-cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 20 sites in Italy.
Trial summary
This is a observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- How many people
- 200 participants
- Where
- 20 sitesItaly
- Study dates
- 5 May 2025to Dec 2027
- Phase
- Observational
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment
Who may be able to join
- Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st January 2019
- Presence of one MYC translocation or gain of copies (GCN: > 3 copies in more than 30% of the nuclei) or amplification evaluated by FISH
- Availability of immunohistochemical analysis of CD10, Bcl6, MUM1, Bcl2, Myc, Ki67
- Have received curative treatment (e.g. R-CHOP, R DA EPOCH, intensified "Burkitt like" chemotherapies) as first-line therapy
- Histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, FISH and other molecular analysis). A FFPE block must be provided for patient enrollment.
- Age between 18 and 79 years
Who cannot join
- Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt's lymphoma, primary mediastinal B lymphoma
- Have received palliative treatment
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
Italy20 sites, 20 recruiting
- Recruiting
A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia
Alessandria
Manuela Zanni, MD, +390131206156, manuela.zanni@ospedale.al.it
Manuela Zanni, MD
- Recruiting
A.O.U. Ospedali Riuniti delle Marche - Clinica di Ematologia
Ancona
Guido Gini, MD, +390715964562, guido.gini@ospedaliriuniti.marche.it
Guido Gini, MD
- Recruiting
I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia
Bari
Sabino Ciavarella, MD, +390805555408, sabinociavarella@yahoo.it
Sabino Ciavarella, MD
- Recruiting
ASST Spedali Civili - S.C. Ematologia
Brescia
Chiara Pagani, MD, +390303996269, chiara.pagani@asst-spedalicivili.it
Chiara Pagani, MD
- Recruiting
I.R.C.C.S. Istituto di Candiolo - FPO
Candiolo
Valentina Sangiorgio, MD, +390119933947, fabiola.sangiorgio@gmail.com
Valentina Sangiorgio, MD
- Not yet recruiting
I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncoematologia
Castelfranco Veneto
Mariella Lo Schirico, MD, +390432732344, mariella.loschirico@iov.veneto.it
Mariella Lo Schirico, MD
- Recruiting
ARNAS Garibaldi - U.O.C. Ematologia
Catania
Ugo Consoli, MD, +390957595055, ugo.consoli144@gmail.com
Ugo Consoli, MD
- Recruiting
A.S.T. Macerata - U.O.S.D Ematologia
Civitanova Marche
Caterina Bocci, MD, +3907332572467, cate.bocci@gmail.com
Caterina Bocci, MD
- Recruiting
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence
Benedetta Sordi, MD, +390557946445, benedetta.sordi@unifi.it
Benedetta Sordi, MD
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia
Milan
Emanuele Ravano, MD, +390264442668, emanuele.ravano@ospedaleniguarda.it
Emanuele Ravano, MD
- Recruiting
Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - S.C. Ematologia
Milan
Francesca Gaia Rossi, MD, +390255033466, francescagaia.rossi@policlinico.mi.it
Francesca Gaia Rossi, MD
- Not yet recruiting
A.O.U. di Padova - U.O.C. Ematologia
Padova
Greta Scapinello, MD, +390498217809, greta.scapinello@aopd.veneto.it
Greta Scapinello, MD
- Not yet recruiting
I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1
Padova
Dario Marino, MD, +390498215621, dario.marino@iov.veneto.it
Dario Marino, MD
- Recruiting
AUSL Modena sede di Sassuolo - UOSD di Oncologia Area Sud
Sassuolo
Sara Bigliardi, MD, +390536846162, s.bigliardi@ausl.mo.it
Sara Bigliardi, MD
- Not yet recruiting
U.O.C. Ematologia - A.O.U. Senese
Siena
Alberto Fabbri, MD, fabbri7@unisi.it
Alberto Fabbri, MD
- Not yet recruiting
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U
Torino
Federica Cavallo, MD, +390116334264, f.cavallo@unito.it
Federica Cavallo, MD
- Recruiting
ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia
Treviso
Piero Maria Stefani, MD, +390422322221, pieromaria.stefani@aulss2.veneto.it
Piero Maria Stefani, MD
- Recruiting
A.O. Cardinale "G. Panico" - U.O.C Ematologia e Trapianto Midollo Osseo
Tricase
Anna Mele, MD, +390833773111, sperimentazionicliniche@piafondazionepanico.it
Anna Mele, MD
- Recruiting
A.S.U. Giuliano Isontina - S.C. Ematologia
Trieste
Elisa Lucchini, MD, +390403992677, elisa.lucchini@asugi.sanita.fvg.it
Elisa Lucchini, MD
- Not yet recruiting
A.O.U.I. di Verona - Ematologia
Verona
Francesca Maria Quaglia, MD, +390458124827, francescamaria.quaglia@aovr.veneto.it
Francesca Maria Quaglia, MD
About this study
Official title: Multicenter, Observational, Retrospective-prospective Study Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma
This is a observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma
Read the detailed description
Diffuse large B-cell lymphomas (DLBCL) and high-grade B-cell lymphomas (HGBCL) are a group of heterogeneous diseases representing more than a third of lymphomas in adults. 5-years overall survival of patients affected by DLBCL and HGBCL is around 70-60% and efficient prognostic markers are warranted to improve patients' survival by better tailored therapeutical approaches.
Genetic rearrangements of the MYC gene occur in 5-10% of DLBCL at diagnosis, and the presence of double translocations involving both MYC and BCL2 ("double-hit", DH), associated or not with BCL6 ("triple-hit", TH) translocation, is associated with unfavorable prognostic impact.
Intensification of treatment compared to standard chemotherapy (R-CHOP) appears to reduce the risk of recurrence in patients with DH or TH lymphomas, but a survival advantage has not been demonstrated.
Numerical changes in MYC (gain of copy number, GCN) may also affect the outcome of patients with DLBCL, but their prognostic relevance and the benefit of treatment intensification is still controversial.
Additionally, novel scientific evidence indicates a contribution of lymphoma micro-environment (LME) in disease genomic subtype and patient prognosis.
We aimed this study at investigating potential biological links between MYC aberrations, lymphoma mutational landscape and functional immune contextures in DLBCL and HGBCL.
- Conditions
- Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- Keywords
- Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, MYC, BCL2, BCL6, Double Hit, Triple Hit, lymphoma micro-environment
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients enrolled | Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the histopathological, genetic, clinical characteristics and outcome of patients with DLBCL or HGBCL with MYC rearrangements or GCN (alone or in association with BCL2 and BCL6) treated with curative intent therapy
Comparison of Progression Free Survival (PFS) according to genetic subgroups with or without intensified treatment
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Secondary outcomes (6)
Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology
% of patients with presence of MYC, BCL2 and/or BCL6 translocation evaluated by FISH
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology
% of patients with presence of MYC gain of copy (GCN: > 3 copies in more than 30% of the nuclei) evaluated by FISH
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology
% of patient with presence of MYC amplification evaluated by FISH
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Identify putative prognostic and predictive biomarkers related to the lymphoma microenvironment
Correlation between the microenvironment signature and patient Overall Survival (OS)
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Analyze the impact of the type of therapy, standard or intensified (with or without autotransplantation), on the outcome in the different subgroups of patients
Progression Free Survival comparison in the different subgroups of lymphomas and according to the type of treatment received
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Assess the risk of central nervous system (CNS) recurrence and the impact of prophylaxis performed with intrathecal chemotherapy vs methotrexate intravenous
Progression Free Survival comparison in the different subgroups of lymphomas and according to the type of treatment received
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luisa Lorenzi, MD, Principal investigator, SC Anatomia Patologica - ASST Spedali Civili di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588205
- Sponsor's protocol ID
- FIL_MIMYC
- Acronym
- FIL_MIMYC
- Status last verified
- Dec 2025
- First submitted
- 2 Sep 2024
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Observational, Retrospective-prospective Study Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06588205
- Acronym / sponsor ID
- FIL_MIMYC / FIL_MIMYC
- Conditions
- Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- Keywords
- Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, MYC, BCL2, BCL6, Double Hit, Triple Hit, lymphoma micro-environment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Sep 2024 (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 observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma
Detailed description
Diffuse large B-cell lymphomas (DLBCL) and high-grade B-cell lymphomas (HGBCL) are a group of heterogeneous diseases representing more than a third of lymphomas in adults. 5-years overall survival of patients affected by DLBCL and HGBCL is around 70-60% and efficient prognostic markers are warranted to improve patients' survival by better tailored therapeutical approaches.
Genetic rearrangements of the MYC gene occur in 5-10% of DLBCL at diagnosis, and the presence of double translocations involving both MYC and BCL2 ("double-hit", DH), associated or not with BCL6 ("triple-hit", TH) translocation, is associated with unfavorable prognostic impact.
Intensification of treatment compared to standard chemotherapy (R-CHOP) appears to reduce the risk of recurrence in patients with DH or TH lymphomas, but a survival advantage has not been demonstrated.
Numerical changes in MYC (gain of copy number, GCN) may also affect the outcome of patients with DLBCL, but their prognostic relevance and the benefit of treatment intensification is still controversial.
Additionally, novel scientific evidence indicates a contribution of lymphoma micro-environment (LME) in disease genomic subtype and patient prognosis.
We aimed this study at investigating potential biological links between MYC aberrations, lymphoma mutational landscape and functional immune contextures in DLBCL and HGBCL.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients enrolled | – | –Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment
Key inclusion criteria (6 listed)
- Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st January 2019
- Presence of one MYC translocation or gain of copies (GCN: > 3 copies in more than 30% of the nuclei) or amplification evaluated by FISH
- Availability of immunohistochemical analysis of CD10, Bcl6, MUM1, Bcl2, Myc, Ki67
- Have received curative treatment (e.g. R-CHOP, R DA EPOCH, intensified "Burkitt like" chemotherapies) as first-line therapy
- Histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, FISH and other molecular analysis). A FFPE block must be provided for patient enrollment.
Key exclusion criteria (2 listed)
- Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt's lymphoma, primary mediastinal B lymphoma
- Have received palliative treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the histopathological, genetic, clinical characteristics and outcome of patients with DLBCL or HGBCL with MYC rearrangements or GCN (alone or in association with BCL2 and BCL6) treated with curative intent therapy
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Comparison of Progression Free Survival (PFS) according to genetic subgroups with or without intensified treatment
6 secondary outcomes
Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Identify putative prognostic and predictive biomarkers related to the lymphoma microenvironment
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Analyze the impact of the type of therapy, standard or intensified (with or without autotransplantation), on the outcome in the different subgroups of patients
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
Assess the risk of central nervous system (CNS) recurrence and the impact of prophylaxis performed with intrathecal chemotherapy vs methotrexate intravenous
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)
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 29 Dec 2025.
- 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.
Luisa Lorenzi, MD principal investigator
SC Anatomia Patologica - ASST Spedali Civili di Brescia
20 sites 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 and High-grade B-cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 20 sites 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 6 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: looking for participants now, as of the sponsor's last update on 29 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 20 sites 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?
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?
Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the histopathological, genetic, clinical characteristics and outcome of patients with DLBCL or HGBCL with MYC rearrangements or GCN (alone or in association with BCL2 and BCL6) treated with curative intent therapy (time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)). 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 29 Dec 2025.