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

This study has been completed.
Sponsor:
Information provided by:
Gruppo Italiano Studio Linfomi
ClinicalTrials.gov Identifier:
NCT01224769
First received: October 7, 2010
Last updated: October 20, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention
Relapsed or Refractory Chronic Lymphoproliferative Disorders
 Drug: bendamustine +/- rituximab

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gruppo Italiano Studio Linfomi:

Primary Outcome Measures:
  • overall response rate [ Time Frame: within 1 month after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • grade III and IV (NCI Common Toxicity Criteria) adverse events [ Time Frame: within 1 month after end of treatment ] [ Designated as safety issue: Yes ]
  • prognostic factors [ Time Frame: within 1 month after end of treatment ] [ Designated as safety issue: No ]
  • progression free survival [ Time Frame: within 1 month after end of treatment ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: within 1 month after end of treatment ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: September 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
bendamustine +/- rituximab Drug: bendamustine +/- rituximab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01224769     History of Changes
Other Study ID Numbers: RETRO-BENDA
Study First Received: October 7, 2010
Last Updated: October 20, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Rituximab
Nitrogen Mustard Compounds
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 18, 2013