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

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)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01990144

Enrollment

Registered

2013-11-21

Start date

2011-11-30

Completion date

2016-02-29

Last updated

2013-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma

Brief 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.

Interventions

DRUGBendamustine+Rituximab

Patients will receive : * Rituximab 375 mg/m2 intravenously on day 1\* * Bendamustine 90 mg/m2 intravenously on days 2 and 3\*\* Treatment will be administered on a 28-day cycle basis. * Administration of rituximab during cycle 1 is postponed to day 8, thereafter on day 1. * After the first cycle, bendamustine can be administered on days 1-2 or days 2-3 according to Institutional/patient/physician choice.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To evaluate the activity of R-B combination in terms of complete response rate (CRR).	4 years
To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.	4 years

Secondary

Measure	Time frame
To evaluate progression free survival (PFS)	4 years
To evaluate overall survival (OS)	4 years

Countries

Italy

Contacts

Primary ContactMarco Calabrese, Dr

segreteria@filinf.it+39 0131 206129

Backup ContactSonia Perticone, Dr