B-cell Lymphomas With MYC RearrangementOSR-CARMENNCT07663175
Safety and Efficacy of Intensified Chemotherapy Regimens in Aggressive B-cell Lymphomas With MYC Rearrangement
An observational study of B-cell Lymphomas With MYC Rearrangement, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
A multicenter, retrospective, observational drug study using anonymized data from adult patients with aggressive B-cell lymphoma treated with the CARMEN regimen. The data were collected during normal clinical practice, therefore neither diagnostic approaches nor experimental drugs/devices will be applied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Lymphomas With MYC Rearrangement
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2022to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with aggressive B-cell lymphoma who have been treated with the CARMEN regimen
Who may be able to join
- Age > 18 years
- Histology of aggressive B-cell lymphoma with MYC rearrangement
- Treatment with CARMEN regimen orwith other chemoimmunotherapy regimens for treatment of aggressive B-cell lymphoma with MYC rearrangement
Who cannot join
- Participation in clinical protocols that expressly exclude the possibility of participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Study of the Safety and Efficacy of Intensified Chemotherapy Regimens in Aggressive B-cell Lymphomas With MYC Rearrangement
A multicenter, retrospective, observational drug study using anonymized data from adult patients with aggressive B-cell lymphoma treated with the CARMEN regimen.
The data were collected during normal clinical practice, therefore neither diagnostic approaches nor experimental drugs/devices will be applied.
Read the detailed description
igh-grade B-cell lymphomas (HGBCL), including Burkitt lymphoma (BL) and MYC-rearranged HGBCL (double-hit and triple-hit lymphomas), are highly aggressive malignancies characterized by rapid proliferation and poor outcomes when treated with standard chemoimmunotherapy regimens such as R-CHOP. Although intensified treatment approaches have improved outcomes in these patients. Over the past decade, the CARMEN regimen has been adopted in several Italian centers as part of routine clinical practice for patients with Burkitt lymphoma and other aggressive B-cell lymphomas characterized by MYC rearrangements. This multicenter, retrospective, observational study aims to evaluate the real-world outcomes of adult patients with aggressive B-cell lymphomas treated with the CARMEN regimen. The study will include consecutive patients diagnosed with Burkitt lymphoma or MYC-rearranged HGBCL, with or without HIV infection, who received CARMEN as first-line therapy during routine clinical practice. Data will be collected retrospectively from participating centers using anonymized patient records.
The primary objectives are to assess the effectiveness and tolerability of the CARMEN regimen in a large real-world population and to describe treatment outcomes, including response rates, progression-free survival, overall survival, relapse patterns, and treatment-related toxicity. Secondary objectives include the evaluation of outcomes according to lymphoma subtype, HIV status, disease characteristics, and consolidation strategies, as well as comparison with outcomes obtained using alternative first-line chemoimmunotherapy regimens employed in clinical practice.
Because this is a non-interventional observational study, no experimental diagnostic procedures, drugs, or medical devices will be administered. All data derive from routine clinical care, and patient management will not be influenced by study participation.
Approximately 500 patients are expected to be included across participating centers. Enrollment is based on retrospective identification of eligible patients treated between November 2022 and November 2027. The study may be suspended or terminated prematurely if the planned sample size cannot be achieved.
- Conditions
- B-cell Lymphomas With MYC Rearrangement
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 treated with the CARMEN regimen | Not described | |
| Patients treated with other chemo-immunotherapy regimens (e.g. GMALL, CODOXM-IVAC, RdaEPOCH, LMB) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free-survival (DFS)
Evaluation of the disease free survival. The Survival will be estimated using the Kaplan-Meier method. Comparison between groups using the log-rank test.
Measured: at 2 years from the treatment
Progression-free survival (PFS)
Evaluation of the progression-free survival (PFS). The Survival will be estimated using the Kaplan-Meier method. Comparison between groups using the log-rank test.
Measured: at 2 years from the treatment
Overall-Survival (OS)
Evaluation of the Overall survival (OS). The Survival will be estimated using the Kaplan-Meier method. Comparison between groups using the log-rank test.
Measured: at 2 years from the treatment
Complete remission rate
Evaluation of the complete remission rate, defined according to Cheson criteria, of experimental intensive chemotherapy
Measured: at 2 years from treatment
Secondary outcomes (4)
Incidence of Treatment-Related Adverse Events and Organ Toxicities During Experimental Intensive Chemotherapy (CARMEN) [Safety and Tolerability]
All patients who received at least the first day of treatment. Treatment-related adverse events and organ toxicities will be evaluated according to the NCI-NCIC Common Toxicity Criteria (CTC), version 3.0. Toxicities will be assessed separately for each treatment phase, and the worst organ toxicity observed in each patient will be considered for analysis.
Measured: at 2 years from the treatment
Incidence of Treatment-Related Adverse Events and Organ Toxicities During Consolidation, Conditioning, and Autologous Stem Cell Transplantation [Safety and Tolerability]
Assessment of Safety and Tolerability of the consolidation phase followed by conditioning and autologous stem cell transplantation through the evaluation of treatment-related adverse events and organ toxicities occurring during these treatment phases, according to the NCI-NCIC CTC version 3.0. Toxicities will be analyzed separately considering the worst organ toxicity observed for each patient.
Measured: at 2 years from the treatment
Incidence of Treatment-Related Adverse Events and Organ Toxicities During Sequential High-Dose Chemotherapy Intensification [Safety and Tolerability]
The tolerability of intensification with sequential high-dose chemotherapy in patients with stable disease after, or progressive disease during or after induction chemotherapy will be assessed through the evaluation of treatment-related adverse events and organ toxicities according to the NCI-NCIC CTC version 3.0. Toxicity assessment will be performed specifically for this treatment phase, and the worst organ toxicity observed in each patient will be considered.
Measured: at 2 years from the treatment
Overall Treatment Response Rate Across the Entire Experimental Intensive Chemotherapy Program
The activity of the entire experimental intensive chemotherapy program will be assessed by evaluating treatment response after induction, after consolidation, and at the end of the entire treatment program using whole-body CT, 18FDG-PET, and other positive baseline tests where applicable. Response will be defined according to the revised response criteria for malignant lymphoma. The investigator-assessed complete response rate will be used as supportive evidence. In patients with positive cerebrospinal fluid at baseline, cytological assessment will be be performed before each intrathecal chemotherapy administration; a reduction greater than 50% in cell count will be considered partial response, whereas a smaller reduction will be considered stable disease. Presence of tumor cells in cerebrospinal fluid will be confirmed by flow cytometry in all samples with ≥4 nucleated cells/μL.
Measured: at 2 years from the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Nov 2022
- 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.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for B-cell Lymphomas With MYC RearrangementStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés José Maria Ferreri, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663175
- Sponsor's protocol ID
- OSR-CARMEN retro
- Acronym
- OSR-CARMEN
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreri AJM, Cattaneo C, Lleshi A, Verga L, Allione B, Facchetti F, Ponzoni M, Foppoli M, Ferrari D, Rigacci L, Pecciarini L, Donadoni G, Fumagalli L, Sassone M, Calimeri T, Rossi G, Spina M, Re A. A dose-dense short-term therapy for human immunodeficiency virus/acquired immunodeficiency syndrome patients with high-risk Burkitt lymphoma or high-grade B-cell lymphoma: safety and efficacy results of the "CARMEN" phase II trial. Br J Haematol. 2021 Jan;192(1):119-128. doi: 10.1111/bjh.17188. Epub 2020 Oct 21.
PubMed 33085777Ferry A, Rieu P, Le Page C, Elhabazi A, Laziri F, Rieu M. Effect of physical exhaustion and glucocorticoids (dexamethasone) on T-cells of trained rats. Eur J Appl Physiol Occup Physiol. 1993;66(5):455-60. doi: 10.1007/BF00599621.
PubMed 8330616Colombo AL, de Almeida Junior JN, Slavin MA, Chen SC, Sorrell TC. Candida and invasive mould diseases in non-neutropenic critically ill patients and patients with haematological cancer. Lancet Infect Dis. 2017 Nov;17(11):e344-e356. doi: 10.1016/S1473-3099(17)30304-3. Epub 2017 Jul 31.
PubMed 28774702Halasz LM, Jacene HA, Catalano PJ, Van den Abbeele AD, Lacasce A, Mauch PM, Ng AK. Combined modality treatment for PET-positive non-Hodgkin lymphoma: favorable outcomes of combined modality treatment for patients with non-Hodgkin lymphoma and positive interim or postchemotherapy FDG-PET. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e647-54. doi: 10.1016/j.ijrobp.2012.01.060. Epub 2012 May 18.
PubMed 22607911Schmidt E, Thoennissen NH, Rudat A, Bieker R, Schliemann C, Mesters RM, Zuhlsdorf M, Muller-Tidow C, Berdel WE. Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis. Ann Oncol. 2008 Sep;19(9):1644-9. doi: 10.1093/annonc/mdn179. Epub 2008 May 2.
PubMed 18453519
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study of the Safety and Efficacy of Intensified Chemotherapy Regimens in Aggressive B-cell Lymphomas With MYC Rearrangement
- ClinicalTrials.gov ID
- NCT07663175
- Acronym / sponsor ID
- OSR-CARMEN / OSR-CARMEN retro
- Conditions
- B-cell Lymphomas With MYC Rearrangement
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jun 2026 (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.
A multicenter, retrospective, observational drug study using anonymized data from adult patients with aggressive B-cell lymphoma treated with the CARMEN regimen.
The data were collected during normal clinical practice, therefore neither diagnostic approaches nor experimental drugs/devices will be applied.
Detailed description
igh-grade B-cell lymphomas (HGBCL), including Burkitt lymphoma (BL) and MYC-rearranged HGBCL (double-hit and triple-hit lymphomas), are highly aggressive malignancies characterized by rapid proliferation and poor outcomes when treated with standard chemoimmunotherapy regimens such as R-CHOP. Although intensified treatment approaches have improved outcomes in these patients. Over the past decade, the CARMEN regimen has been adopted in several Italian centers as part of routine clinical practice for patients with Burkitt lymphoma and other aggressive B-cell lymphomas characterized by MYC rearrangements. This multicenter, retrospective, observational study aims to evaluate the real-world outcomes of adult patients with aggressive B-cell lymphomas treated with the CARMEN regimen. The study will include consecutive patients diagnosed with Burkitt lymphoma or MYC-rearranged HGBCL, with or without HIV infection, who received CARMEN as first-line therapy during routine clinical practice. Data will be collected retrospectively from participating centers using anonymized patient records.
The primary objectives are to assess the effectiveness and tolerability of the CARMEN regimen in a large real-world population and to describe treatment outcomes, including response rates, progression-free survival, overall survival, relapse patterns, and treatment-related toxicity. Secondary objectives include the evaluation of outcomes according to lymphoma subtype, HIV status, disease characteristics, and consolidation strategies, as well as comparison with outcomes obtained using alternative first-line chemoimmunotherapy regimens employed in clinical practice.
Because this is a non-interventional observational study, no experimental diagnostic procedures, drugs, or medical devices will be administered. All data derive from routine clinical care, and patient management will not be influenced by study participation.
Approximately 500 patients are expected to be included across participating centers. Enrollment is based on retrospective identification of eligible patients treated between November 2022 and November 2027. The study may be suspended or terminated prematurely if the planned sample size cannot be achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with the CARMEN regimen | – | – |
| Patients treated with other chemo-immunotherapy regimens (e.g. GMALL, CODOXM-IVAC, RdaEPOCH, LMB) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with aggressive B-cell lymphoma who have been treated with the CARMEN regimen
Key inclusion criteria (3 listed)
- Age > 18 years
- Histology of aggressive B-cell lymphoma with MYC rearrangement
- Treatment with CARMEN regimen orwith other chemoimmunotherapy regimens for treatment of aggressive B-cell lymphoma with MYC rearrangement
Key exclusion criteria (1 listed)
- Participation in clinical protocols that expressly exclude the possibility of participation in other studies
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
Disease-free-survival (DFS)
Time frame: at 2 years from the treatment
Evaluation of the disease free survival. The Survival will be estimated using the Kaplan-Meier method. Comparison between groups using the log-rank test.
Progression-free survival (PFS)
Time frame: at 2 years from the treatment
Evaluation of the progression-free survival (PFS). The Survival will be estimated using the Kaplan-Meier method. Comparison between groups using the log-rank test.
Overall-Survival (OS)
Time frame: at 2 years from the treatment
Evaluation of the Overall survival (OS). The Survival will be estimated using the Kaplan-Meier method. Comparison between groups using the log-rank test.
Complete remission rate
Time frame: at 2 years from treatment
Evaluation of the complete remission rate, defined according to Cheson criteria, of experimental intensive chemotherapy
4 secondary outcomes
Incidence of Treatment-Related Adverse Events and Organ Toxicities During Experimental Intensive Chemotherapy (CARMEN) [Safety and Tolerability]
Time frame: at 2 years from the treatment
Incidence of Treatment-Related Adverse Events and Organ Toxicities During Consolidation, Conditioning, and Autologous Stem Cell Transplantation [Safety and Tolerability]
Time frame: at 2 years from the treatment
Incidence of Treatment-Related Adverse Events and Organ Toxicities During Sequential High-Dose Chemotherapy Intensification [Safety and Tolerability]
Time frame: at 2 years from the treatment
Overall Treatment Response Rate Across the Entire Experimental Intensive Chemotherapy Program
Time frame: at 2 years from the treatment
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 26 Jun 2026.
- Background: PubMed 33085777Ferreri AJM, Cattaneo C, Lleshi A, Verga L, Allione B, Facchetti F, Ponzoni M, Foppoli M, Ferrari D, Rigacci L, Pecciarini L, Donadoni G, Fumagalli L, Sassone M, Calimeri T, Rossi G, Spina M, Re A. A dose-dense short-term therapy for human immunodeficiency virus/acquired immunodeficiency syndrome patients with high-risk Burkitt lymphoma or high-grade B-cell lymphoma: safety and efficacy results of the "CARMEN" phase II trial. Br J Haematol. 2021 Jan;192(1):119-128. doi: 10.1111/bjh.17188. Epub 2020 Oct 21.
- Background: PubMed 8330616Ferry A, Rieu P, Le Page C, Elhabazi A, Laziri F, Rieu M. Effect of physical exhaustion and glucocorticoids (dexamethasone) on T-cells of trained rats. Eur J Appl Physiol Occup Physiol. 1993;66(5):455-60. doi: 10.1007/BF00599621.
- Background: PubMed 28774702Colombo AL, de Almeida Junior JN, Slavin MA, Chen SC, Sorrell TC. Candida and invasive mould diseases in non-neutropenic critically ill patients and patients with haematological cancer. Lancet Infect Dis. 2017 Nov;17(11):e344-e356. doi: 10.1016/S1473-3099(17)30304-3. Epub 2017 Jul 31.
- Background: PubMed 22607911Halasz LM, Jacene HA, Catalano PJ, Van den Abbeele AD, Lacasce A, Mauch PM, Ng AK. Combined modality treatment for PET-positive non-Hodgkin lymphoma: favorable outcomes of combined modality treatment for patients with non-Hodgkin lymphoma and positive interim or postchemotherapy FDG-PET. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e647-54. doi: 10.1016/j.ijrobp.2012.01.060. Epub 2012 May 18.
- Background: PubMed 18453519Schmidt E, Thoennissen NH, Rudat A, Bieker R, Schliemann C, Mesters RM, Zuhlsdorf M, Muller-Tidow C, Berdel WE. Use of palifermin for the prevention of high-dose methotrexate-induced oral mucositis. Ann Oncol. 2008 Sep;19(9):1644-9. doi: 10.1093/annonc/mdn179. Epub 2008 May 2.
- 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?
An observational study of B-cell Lymphomas With MYC Rearrangement, run by IRCCS San Raffaele 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 3 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 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 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?
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?
Disease-free-survival (DFS) (time frame: at 2 years from the treatment). The study lists 4 primary outcomes in all. 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 NCT07663175, which also lists 5 linked publications.
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 26 Jun 2026.