Safety and Efficacy of Intensified Chemotherapy Regimens in Aggressive B-cell Lymphomas With MYC Rearrangement (OSR-CARMEN)

June 23, 2026 updated by: Andrés José Maria Ferreri, IRCCS San Raffaele

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy
      • Milan, Italy, Italy, 20132
        • IRCCS Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult patients with aggressive B-cell lymphoma who have been treated with the CARMEN regimen

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Participation in clinical protocols that expressly exclude the possibility of participation in other studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients treated with the CARMEN regimen
Patients treated with other chemo-immunotherapy regimens (e.g. GMALL, CODOXM-IVAC, RdaEPOCH, LMB)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 2 years from the treatment
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.
at 2 years from the treatment
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.
at 2 years from the treatment
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
at 2 years from treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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
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.
at 2 years from the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 11, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 23, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 23, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • OSR-CARMEN retro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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