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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief 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.

Detailed Summary:

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%.


Sponsor: Fondazione Italiana Linfomi ONLUS

Current Primary Outcome: Cardiotoxicity [ Time Frame: 1 year from enrollment ]

defined as the rate of cardiovascular events classified according to the Lenihan criteria 2013


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall response rate (ORR) [ Time Frame: 6 months from enrollment ]
    defined according to international criteria (Cheson 2007)
  • Rate of response to treatment [ Time Frame: 6 months from enrollment ]
    defined according to international criteria (Cheson 2007)
  • Overall survival (OS [ Time Frame: 3 years from enrollment ]
    It will be calculated for all patients enrolled in the study from the date of start of therapy to the date of death or last follow-up.
  • Progression-free survival (PFS) [ Time Frame: 3 years from enrollment ]
    It will be calculated for all patients from the start of therapy given to the date of progression or death or last follow-up.
  • failure-free survival (FFS) [ Time Frame: 3 years from enrollment ]

    It will be calculated for all patients from the therapy start date to the date of an event or last follow-up.

    The events considered for the FFS definition are the following: treatment discontinuation for toxicity, response <RC, relapse / progression, death for any cause.

  • Freedom From cardiovascular Event (FFCE) [ Time Frame: 3 years from enrollment ]
    calculated for all patients from the therapy start date to the time of occurrence of a cardiovascular event as defined by primary endopoint or follow-up date.
  • Number of events recorded during the treatment and codified according to NCI-CTC v4.03 [ Time Frame: 3 years from enrollment ]
    it will be defined by the number of events recorded during the treatment and codified according to NCI-CTC v4.03


Original Secondary Outcome: Same as current

Information By: Fondazione Italiana Linfomi ONLUS

Dates:
Date Received: September 21, 2016
Date Started: January 2014
Date Completion: January 2018
Last Updated: March 22, 2017
Last Verified: March 2017