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

Overview

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.

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 2010

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Progression Free Survival (PFS) and Overall Survival (OS)
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

  • patients with relapsed or refractory chronic lymphoproliferative disorders – salvage treatment with Bendamustine +/- Rituximab – age ≥ 18 years Exclusion Criteria:

  • previous treatment with Bendamustine

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gruppo Italiano Studio Linfomi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Stefano Luminari, MD, Study Director, Gruppi Italiano Studi Linfomi
    • Emilio Iannitto, MD, Principal Investigator, Gruppo Italiano Studio Linfomi

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