Rituximab Plus Bendamustine as Front Line Treatment in Frail Elderly (>70 Years) Patients With DLBCL: a Phase II Multicenter Study of the FIL

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate feasibility and efficacy of rituximab-bendamustine (R-B)combination in elderly patients affected by diffuse large B-cell lymphoma and defined as frail according to CGA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Fondazione Italiana Linfomi ONLUS
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

Inclusion Criteria:

• 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) Age > 80 years with UNFIT profile, i.e.

• ADL > 5 residual functions

• IADL > 6 residual functions

• CIRS 5-8 co-morbidities of grade 2

or Age < 80 years with

• ADL < 4 residual functions, or

• IADL < 5 residual functions, or

• CIRS : 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

Exclusion Criteria:

• 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