Efficacy and Safety Study of Bendamustine With or Without Rituximab in Chronic Lymphoproliferative Disorders

A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, As Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01832597

Enrollment

109

Registered

2013-04-16

Start date

2010-11-30

Completion date

2011-01-31

Last updated

2013-04-16

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

Conditions

Chronic Lymphocytic Leukaemia

Brief summary

The purpose of this study is collect and evaluate the clinical experience reached in Italy on the use of bendamustine alone or combined with rituximab as treatment of patients with relapsed or refractory chronic lymphoproliferative disorders.

Detailed description

All patients who meet the criteria for inclusion will be included in the study. A specific database will be created to collect the following information: personal data, medical history, histology related to the underlying disease, comorbidities, laboratory data, initial staging, data on the dosage and the number of cycles administered, the recorded toxicity data, the clinical response and the main events (relapse, progression, death, and cause of death). These data will then be retrospectively examined in order to obtain information about the life-saving treatment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients with relapsed or refractory chronic lymphoproliferative disorders * salvage treatment with Bendamustine +/- Rituximab * age ≥ 18 years

Exclusion criteria

* previous treatment with Bendamustine

Design outcomes

Primary

Measure	Time frame	Description
Overall Response Rate (ORR)	At least 2 months after completion of therapy	Evaluate the activity of Bendamustine +/- Rituximab in term of ORR

Secondary

Measure	Time frame	Description
Progression Free Survival (PFS) and Overall Survival (OS)	From the date of frist treatment cycle until the date of first documented progression or date of death for any cause, whichever came first, assessed up to 150 months	Evaluate the activity of Bendamustine +/- Rituximab in term of PFS and OS
Number of Adverse Events	From the date of first tratment cycle until 6 months after the date of last treatment cycle	Assess to efficacy of Bendamustine +/- Rituximab in term of grade III and IV National Cancer Institute Common Toxicity Criteria (NCI CTC) adverse events

Countries

Italy

Outcome results