Study Investigating the Cardiotoxicity of Anthracyclines in Patients With Diffuse Large B-Cell

Lymphoma Clinical Trial

Official title: Prospective Observational Study Investigating the Cardiotoxicity of Anthracyclines in Patients With Diffuse Large B-Cell

Status Active, not recruiting

Clinical Trial Summary

All patients enrolled in the study will have to be treated with a chemo immunotherapy scheme R-CHOP with doxorubicin, with doxorubicin analogue or non pegylated liposomal anthracycline (R-COMP; Sec. 648 DM) administered every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.

Clinical Trial Description

The study was designed as a prospective observational multicenter study to evaluate the role of possible early markers of cardiotoxicity estimating an overall maximum risk equal to 20% of patients. The sample size, required to obtain an estimate of conventional anthracycline cardiotoxicity in the population, has been calculated with a confidence interval of 95% and a maximum acceptable error of ± 0.075. According to the conditions described above, the sample size of patients treated with conventional anthracycline results to be 124 patients.

Considering a 10-15% of not evaluable patients, the sample size is fixed at 150 patients treated with R-CHOP. The duration of the enrollment phase is defined in 2 years.

With this sample size should be possible to assess the risk of cardiotoxicity related to predictors with a worst group frequency at least of 10%. ;

Related Conditions & MeSH terms

• Cardiotoxicity
• Diffuse Large B-Cell
• Large B-Cell
• Lymphoma

• NCT number: NCT02916316
• Study type: Observational
• Source: Fondazione Italiana Linfomi - ETS
• Status: Active, not recruiting
• Start date: February 12, 2014
• Completion date: December 2024