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

NCT ID: NCT01832597

Last Updated: 2013-04-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 109 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-01-31

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.

Conditions

Chronic Lymphocytic Leukaemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• previous treatment with Bendamustine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gruppo Italiano Studio Linfomi

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Luminari, MD

Role: STUDY_DIRECTOR

Gruppi Italiano Studi Linfomi

Emilio Iannitto, MD

Role: PRINCIPAL_INVESTIGATOR

Gruppo Italiano Studio Linfomi

Locations

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

Countries

Italy

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Other Identifiers

RetroBENDA

Identifier Type: -

Identifier Source: org_study_id