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

Sponsor
Gruppo Italiano Studio Linfomi (Other)
Overall Status
Completed
CT.gov ID
NCT01832597
Collaborator
(none)
109
Enrollment
3
Locations
2
Duration (Months)
36.3
Patients Per Site
18.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    109 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    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 Start Date :
    Nov 1, 2010
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Jan 1, 2011

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients with relapsed or refractory chronic lymphoproliferative disorders

    • salvage treatment with Bendamustine +/- Rituximab

    • age ≥ 18 years

    Exclusion Criteria:
    • previous treatment with Bendamustine

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UO di Ematologia, S.O. Annunziata Cosenza CZ Italy 87100
    2 Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Universita' di Modena e Reggio Emilia Modena MO Italy 41124
    3 UO di Ematologia, AOUP Paolo Giaccone, Palermo PA Italy 90127

    Sponsors and Collaborators

    • Gruppo Italiano Studio Linfomi

    Investigators

    • Study Director: Stefano Luminari, MD, Gruppi Italiano Studi Linfomi
    • Principal Investigator: Emilio Iannitto, MD, Gruppo Italiano Studio Linfomi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gruppo Italiano Studio Linfomi
    ClinicalTrials.gov Identifier:
    NCT01832597
    Other Study ID Numbers:
    • RetroBENDA
    First Posted:
    Apr 16, 2013
    Last Update Posted:
    Apr 16, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Leukemia, Lymphocytic, Chronic, B-Cell
    Lymphoproliferative Disorders

    Study Results

    No Results Posted as of Apr 16, 2013