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

NCT01832597 | Completed DMC

• 1 other identifier: RetroBENDA
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Lymphocytic Leukaemia

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

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

  At least 2 months after completion of therapy

Secondary Outcomes (2)

• 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

• Number of Adverse Events

  From the date of first tratment cycle until 6 months after the date of last treatment cycle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with relapsed or refractory chronic lymphoproliferative disorders treated with Bendamustine +/- Rituximab

You may qualify if:

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

You may not qualify if:

• previous treatment with Bendamustine

Sponsors & Collaborators

• Gruppo Italiano Studio Linfomi: lead

Study Sites (3)

UO di Ematologia, S.O. Annunziata

Cosenza, CZ, 87100, Italy

Location

Dipartimento di Oncologia, Ematologia e Patologie dell'Apparato Respiratorio, Universita' di Modena e Reggio Emilia

Modena, MO, 41124, Italy

Location

UO di Ematologia, AOUP Paolo Giaccone,

Palermo, PA, 90127, Italy

Location

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MeSH Terms

Conditions

Leukemia, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Stefano Luminari, MD

  Gruppi Italiano Studi Linfomi

  STUDY DIRECTOR

• Emilio Iannitto, MD

  Gruppo Italiano Studio Linfomi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 16, 2013
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: April 16, 2013

Record last verified: 2013-04

Locations

IT (3)