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CompletedNCT01224769Updated Oct 21, 2010

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

An observational study in Relapsed or Refractory Chronic Lymphoproliferative Disorders, sponsored by Gruppo Italiano Studio Linfomi. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-21.

Sponsored by Gruppo Italiano Studio Linfomi · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
109
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsed or Refractory Chronic Lymphoproliferative Disorders
03

In context

Lymphoproliferative Disorders

231 studies on the registry are indexed under Lymphoproliferative Disorders; 45 are open to participants now.

This study's enrollment of 109 is below the median of 241 across 37 observational studies indexed under Lymphoproliferative Disorders.

Browse Lymphoproliferative Disorders studies →

Lead sponsor

Gruppo Italiano Studio Linfomi is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with relapsed or refractory chronic lymphoproliferative disorders treated with bendamustine +/- rituximab

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • previous treatment with bendamustine
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
109 participants (actual)

Groups and cohorts

  • bendamustine +/- rituximab

    Drug: bendamustine +/- rituximab

Interventions

  • Drugbendamustine +/- rituximab
06

What researchers measure

Primary outcomes

  1. overall response rate

    Time frame: within 1 month after end of treatment

Secondary outcomes

  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

07

Study locations

1 site
  • Gruppo Italiano Studio Linfomi
    Modena, 41124, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01224769
Lead sponsor
Gruppo Italiano Studio Linfomi
First posted
Oct 20, 2010
Start date
Sep 2005
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Oct 21, 2010

Study contacts

Emilio Iannitto, MD
study chair · Gruppo Italiano Studio Linfomi
Fortunato Morabito, MD
study director · Gruppo Italiano Studio Linfomi
Stefano Luminari, MD
principal investigator · Gruppo Italiano Studio Linfomi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.

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