A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, As Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 109
- Locations
- 3
- Primary Endpoint
- Overall Response Rate (ORR)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with relapsed or refractory chronic lymphoproliferative disorders
- •salvage treatment with Bendamustine +/- Rituximab
- •age ≥ 18 years
Exclusion Criteria
- •previous treatment with Bendamustine
Outcomes
Primary Outcomes
Overall Response Rate (ORR)
Time Frame: At least 2 months after completion of therapy
Evaluate the activity of Bendamustine +/- Rituximab in term of ORR
Secondary Outcomes
- 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)
- Number of Adverse Events(From the date of first tratment cycle until 6 months after the date of last treatment cycle)