NCT01832597

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
• Phase: —
• Study type: Observational
• Enrollment: 109 (actual)
• Sponsor: Gruppo Italiano Studio Linfomi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukaemia

Timeline

• Start date: 2010-11-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2013-04-16
• Last updated: 2013-04-16

Locations

3 sites across 1 country: Italy