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OpenTrials
Completed

NCT Number: NCT01832597

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukaemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UO di Ematologia, S.O. Annunziata, Cosenza, CZ, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • previous treatment with Bendamustine

Treatment and study plan

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: At least 2 months after completion of therapy

    Evaluate the activity of Bendamustine +/- Rituximab in term of ORR

Secondary outcomes

  1. Progression Free Survival (PFS) and Overall Survival (OS)

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Studio Linfomi

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Apr 16, 2013
Registry last updated
Apr 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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