Diffuse Non-Hodgkin`s lymphoma, large B cells of the cardiopathic patient MedDRA version: 9.1 Level: PT Classification code 10012818
Conditions
Interventions
Trade Name: MYOCET
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorubicin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
IIL INTERGRUPPO ITALIANO LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. NHL histological diagnosis of diffuse large B cell CD20 + (de novo or shift from low-grade NHL if not pretreated), grade IIIb follicular NHL; 2.Age >= 18 years; 3.Presence of at least 1 factor that defines the cardiopathy(see Annex F); 4.Life expectancy > 3 months; 5.In the case of women of childbearing age absence of pregnancy at the beginning of the chemotherapy; 6.Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Histology different from NHL diffuse large cell CD20 + or follicular IIIb 2.Age 2 times the standard; 7.Bilirubin > 2 times the standard; 8.Creatinina > 2.5 mg / dl; 9.Location of CNS disease; 10.Pregnancy ongoing; 11.Damage to that organ or medical problems that could interfere with the therapy; 12.Current uncontrolled infection; 13.Senile dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility of R-COMP in cardiopathic patients;Secondary Objective: - Response Rates - Progression free Survival - Overall Survival;Primary end point(s): Response Rates at 1 year Progression free Survival at 1 year | — |
Countries
Italy
Outcome results
None listed