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A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, As Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders


N/A
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukaemia

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Trial Information

A Retrospective Multicenter Trial on Efficacy and Toxicity of Bendamustine Alone or Associated With Rituximab, As Salvage Therapy in Patients With Chronic Lymphoproliferative Disorders


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.


Inclusion Criteria:



- patients with relapsed or refractory chronic lymphoproliferative disorders

- salvage treatment with Bendamustine +/- Rituximab

- age ≥ 18 years

Exclusion Criteria:

- previous treatment with Bendamustine

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

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

Outcome Time Frame:

At least 2 months after completion of therapy

Safety Issue:

No

Principal Investigator

Stefano Luminari, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gruppi Italiano Studi Linfomi

Authority:

Italy: The Italian Medicines Agency

Study ID:

RetroBENDA

NCT ID:

NCT01832597

Start Date:

November 2010

Completion Date:

January 2011

Related Keywords:

  • Chronic Lymphocytic Leukaemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoproliferative Disorders

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