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

Completed

• Conditions: Relapsed or Refractory Chronic Lymphoproliferative Disorders
• Interventions: Drug: bendamustine +/- rituximab

• Registration Number: NCT01224769
• Lead Sponsor: Gruppo Italiano Studio Linfomi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-10
• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Submitted: 2010-10-20
• Last Update Posted: 2010-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bendamustine +/- rituximab	bendamustine +/- rituximab	-

Primary Outcome Measures

Name	Time	Method
overall response rate	within 1 month after end of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Gruppo Italiano Studio Linfomi; 🇮🇹 Modena, Italy