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)

• Conditions: Patients with diffuse large B-cell non-Hodgkin’s lymphoma in frail elderly (=70 years) patients; MedDRA version: 14.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2011-001421-24-IT
• Lead Sponsor: FONDAZIONE ITALIANA LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-21
• Last Update Posted: 3 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To evaluate the activity of R-B combination in terms of complete response rate (CRR). •To evaluate the safety and tolerability of R-B combination in terms of rate of adverse events occurrence.;Secondary Objective: •To evaluate progression free survival (PFS). •To evaluate overall survival (OS).;Primary end point(s): Efficacy of R-Bendamustin measured by Complete Response rate. Complete response rate will be evaluated according to Cheson criteria; Cheson 1999 criteria will be used for response evaluation on CT-scan; in the case of PET availability, response will be assessed on PET according to the Cheson 2007 criteria.;Timepoint(s) of evaluation of this end point: 32 weeks from beginning of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): ?2-year Progression free survival (PFS), defined as the time from entry into the study until lymphoma relapse/ progression or death as a result of any cause. Responding patients, patients who are lost to follow up, who withdrawal the consent or drop-out due to adverse event will be censored at their last assessment date. Patients died due to tumor will be considered in progression. Patients died for any other cause will be censored to the death date. ?2-year Overall survival (OS), defined as the time from the date of treatment start into the study until the date of death irrespective of cause. Patients who have not died at the time of end of the whole study, and patients who are lost to follow up, will be censored at the date of the last contact The complete response rate will be estimated with the 95% confidence interval. Time to event data (PFS, OS) will be estimated using the Kaplan-Meier method.;Timepoint(s) of evaluation of this end point: 2 years from beginning of treatment