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Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders

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ClinicalTrials.gov Identifier: NCT01224769
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : October 21, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
This retrospective study collects and evaluates 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
Relapsed or Refractory Chronic Lymphoproliferative Disorders Drug: bendamustine +/- rituximab

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 : September 2005
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
bendamustine +/- rituximab Drug: bendamustine +/- rituximab


Outcome Measures

Primary Outcome Measures :
  1. overall response rate [ Time Frame: within 1 month after end of treatment ]

Secondary Outcome Measures :
  1. grade III and IV (NCI Common Toxicity Criteria) adverse events [ Time Frame: within 1 month after end of treatment ]
  2. prognostic factors [ Time Frame: within 1 month after end of treatment ]
  3. progression free survival [ Time Frame: within 1 month after end of treatment ]
  4. overall survival [ Time Frame: within 1 month after end of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with relapsed or refractory chronic lymphoproliferative disorders treated with bendamustine +/- rituximab
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224769


Locations
Italy
Gruppo Italiano Studio Linfomi
Modena, Italy, 41124
Sponsors and Collaborators
Gruppo Italiano Studio Linfomi
Investigators
Study Chair: Emilio Iannitto, MD Gruppo Italiano Studio Linfomi
Study Director: Fortunato Morabito, MD Gruppo Italiano Studio Linfomi
Principal Investigator: Stefano Luminari, MD Gruppo Italiano Studio Linfomi
More Information

ClinicalTrials.gov Identifier: NCT01224769     History of Changes
Other Study ID Numbers: RETRO-BENDA
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 21, 2010
Last Verified: October 2010

Additional relevant MeSH terms:
Disease
Lymphoproliferative Disorders
Pathologic Processes
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action