NCT01224769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
Last Updated

October 21, 2010

Status Verified

October 1, 2010

Enrollment Period

4.3 years

First QC Date

October 7, 2010

Last Update Submit

October 20, 2010

Conditions

Relapsed or Refractory Chronic Lymphoproliferative Disorders

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    within 1 month after end of treatment

Secondary Outcomes (4)

  • grade III and IV (NCI Common Toxicity Criteria) adverse events

    within 1 month after end of treatment

  • prognostic factors

    within 1 month after end of treatment

  • progression free survival

    within 1 month after end of treatment

  • overall survival

    within 1 month after end of treatment

Study Arms (1)

bendamustine +/- rituximab

Drug: bendamustine +/- rituximab

Interventions

bendamustine +/- rituximabDRUG
bendamustine +/- rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gruppo Italiano Studio Linfomi

Modena, 41124, Italy

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Emilio Iannitto, MD

    Gruppo Italiano Studio Linfomi

    STUDY CHAIR

  • Fortunato Morabito, MD

    Gruppo Italiano Studio Linfomi

    STUDY DIRECTOR

  • Stefano Luminari, MD

    Gruppo Italiano Studio Linfomi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2010

First Posted

October 20, 2010

Study Start

September 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

October 21, 2010

Record last verified: 2010-10

Locations

IT(1)