Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders

October 20, 2010 updated by: Gruppo Italiano Studio Linfomi

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

This retrospective study collects and evaluates 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Modena, Italy, 41124
        • Gruppo Italiano Studio Linfomi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with relapsed or refractory chronic lymphoproliferative disorders treated with bendamustine +/- rituximab

Description

Inclusion Criteria:

  • patients with relapsed or refractory chronic lymphoproliferative disorders
  • salvage treatment with bendamustine +/- rituximab
  • age ≥ 18 years

Exclusion Criteria:

  • previous treatment with bendamustine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bendamustine +/- rituximab
Drug: bendamustine +/- rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall response rate
Time Frame: within 1 month after end of treatment
within 1 month after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
grade III and IV (NCI Common Toxicity Criteria) adverse events
Time Frame: within 1 month after end of treatment
within 1 month after end of treatment
prognostic factors
Time Frame: within 1 month after end of treatment
within 1 month after end of treatment
progression free survival
Time Frame: within 1 month after end of treatment
within 1 month after end of treatment
overall survival
Time Frame: within 1 month after end of treatment
within 1 month after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Studio Linfomi

Investigators

  • Study Chair: Emilio Iannitto, MD, Gruppo Italiano Studio Linfomi
  • Study Director: Fortunato Morabito, MD, Gruppo Italiano Studio Linfomi
  • Principal Investigator: Stefano Luminari, MD, Gruppo Italiano Studio Linfomi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2010

Last Update Submitted That Met QC Criteria

October 20, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RETRO-BENDA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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