Clinical trial NCT01832597: Efficacy and Safety Study of Bendamustine With or Without Rituximab in Chronic Lymphoproliferative Disorders
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukaemia
Lead sponsor: Gruppo Italiano Studio Linfomi
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with relapsed or refractory chronic lymphoproliferative disorders treated with Bendamustine +/- Rituximab

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.

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

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: At least 2 months after completion of therapy
Secondary outcomes:
measure: Progression Free Survival (PFS) and Overall Survival (OS)
timeFrame: 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
measure: Number of Adverse Events
timeFrame: From the date of first tratment cycle until 6 months after the date of last treatment cycle
Other outcomes:
Locations:
city: Cosenza
country: Italy
facility: UO di Ematologia, S.O. Annunziata
state: CZ
city: Modena
country: Italy
facility: Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Universita' di Modena e Reggio Emilia
state: MO
city: Palermo
country: Italy
facility: UO di Ematologia, AOUP Paolo Giaccone,
state: PA
Study officials:
affiliation: Gruppi Italiano Studi Linfomi
name: Stefano Luminari, MD
role: STUDY_DIRECTOR
affiliation: Gruppo Italiano Studio Linfomi
name: Emilio Iannitto, MD
role: PRINCIPAL_INVESTIGATOR
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