Clinical trial · Observational
Safety and Efficacy of Intensified Chemotherapy Regimens in Aggressive B-cell Lymphomas With MYC Rearrangement
A Retrospective Observational Study of the Safety and Efficacy of Intensified Chemotherapy Regimens in Aggressive B-cell Lymphomas With MYC Rearrangement
NCT07663175CI-TRIAL-00116037OSR-CARMENactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphomas With MYC Rearrangement | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients treated with the CARMEN regimen
- label
- Patients treated with other chemo-immunotherapy regimens (e.g. GMALL, CODOXM-IVAC, RdaEPOCH, LMB)
Primary outcomes (4)
- measure
- Disease-free-survival (DFS)
- timeFrame
- at 2 years from the treatment
- description
- Evaluation of the disease free survival. The Survival will be estimated using the Kaplan-Meier method. Comparison between groups using the log-rank test.
- measure
- Progression-free survival (PFS)
- timeFrame
- at 2 years from the treatment
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDFerreri 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
- BACKGROUNDFerry 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
- BACKGROUNDColombo 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
- BACKGROUNDHalasz 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
- BACKGROUNDSchmidt 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