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

NCT07663175 | Active Not Recruiting

• 1 other identifier: OSR-CARMEN retro
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B-cell Lymphomas With MYC Rearrangement

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  at 2 years from the treatment

• Complete remission rate

  Evaluation of the complete remission rate, defined according to Cheson criteria, of experimental intensive chemotherapy

  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]

  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]

  at 2 years from the treatment

• Incidence of Treatment-Related Adverse Events and Organ Toxicities During Sequential High-Dose Chemotherapy Intensification [Safety and Tolerability]

  at 2 years from the treatment

• Overall Treatment Response Rate Across the Entire Experimental Intensive Chemotherapy Program

  at 2 years from the treatment

Study Arms (2)

Patients treated with the CARMEN regimen

Patients treated with other chemo-immunotherapy regimens (e.g. GMALL, CODOXM-IVAC, RdaEPOCH, LMB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

Location

Related Publications (5)

• 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.

  PMID: 33085777 BACKGROUND

• Ferry 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.

  PMID: 8330616 BACKGROUND

• Colombo 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.

  PMID: 28774702 BACKGROUND

• Halasz 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.

  PMID: 22607911 BACKGROUND

• Schmidt 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.

  PMID: 18453519 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 23, 2026
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)