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

Completed

• Conditions: Chronic Lymphocytic Leukaemia

• Registration Number: NCT01832597
• Lead Sponsor: Gruppo Italiano Studio Linfomi

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 Timeline

• Study Start: 2010-11
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2013-04
• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-12
• Last Update Submitted: 2013-04-12
• Study First Posted: 2013-04-16
• Last Update Posted: 2013-04-16

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

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	At least 2 months after completion of therapy	Evaluate the activity of Bendamustine +/- Rituximab in term of ORR

Secondary Outcome Measures

Name	Time	Method
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	Evaluate the activity of Bendamustine +/- Rituximab in term of PFS and OS
Number of Adverse Events	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

Trial Locations

Locations (3)

UO di Ematologia, S.O. Annunziata; 🇮🇹 Cosenza, CZ, Italy

Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Universita' di Modena e Reggio Emilia; 🇮🇹 Modena, MO, Italy

UO di Ematologia, AOUP Paolo Giaccone,; 🇮🇹 Palermo, PA, Italy