Rituximab plus Bendamustine as front line treatment in frail elderly (=70 years) patients with diffuse large B-cell non-Hodgkin’s lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi (FIL) - FIL_R-BENDA FRAI

FONDAZIONE ITALIANA LINFOMI ONLUS0 sitesDecember 21, 2011

Overview

No summary available.

Registry

who.int

Start Date

December 21, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

FONDAZIONE ITALIANA LINFOMI ONLUS

•Histologically proven CD20 positive diffuse large B\-cell non\-Hodgkin’s lymphoma •Age \= 70 years •No previous treatment •FRAIL patients defined as follows (see Appendices B\-E of the protocol): Age \> 80 years with UNFIT profile, i.e. oADL \> 5 residual functions oIADL \> 6 residual functions oCIRS 5\-8 co\-morbidities of grade 2 or Age \< 80 years with oADL \< 4 residual functions, or oIADL \< 5 residual functions, or oCIRS : 1 co\-morbidity of grade 3\-4, or \> 8 co\-morbidities of grade 2 •Life expectancy \> 6 months •Written informed consent •Accessibility of patient for treatment and follow up
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•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 49

•History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer •Previous exposure to cytotoxic agents •Suspect or clinical evidence of CNS involvement by lymphoma •HBsAg, HCV or HIV positivity; HBcAb positivity is accepted only with concomitant treatment with Lamivudine •AST /ALT \> twice upper the normal range; bilirubin \> twice upper the normal range; serum creatinine \> 2\.5 mg /dl •Evidence of any severe active acute or chronic infection •Concurrent co\-morbid medical condition which might exclude administration of full dose chemotherapy •Senile dementia •Any other co\-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent