Relapsed or Refractory Chronic Lymphoproliferative DisordersNCT01224769
Bendamustine and Rituximab As Salvage Therapy In Patients With Chronic Lymphoproliferative Disorders
An observational study of Relapsed or Refractory Chronic Lymphoproliferative Disorders, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Chronic Lymphoproliferative Disorders
- What is being tested?
- bendamustine +/- rituximab
- How many people
- 109 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2005to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with relapsed or refractory chronic lymphoproliferative disorders treated with bendamustine +/- rituximab
Who may be able to join
- patients with relapsed or refractory chronic lymphoproliferative disorders
- salvage treatment with bendamustine +/- rituximab
- age ≥ 18 years
Who cannot join
- previous treatment with bendamustine
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- bendamustine +/- rituximab
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bendamustine +/- rituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| bendamustine +/- rituximab | Not described Receives: Drug: bendamustine +/- rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate
Measured: within 1 month after end of treatment
Secondary outcomes (4)
grade III and IV (NCI Common Toxicity Criteria) adverse events
Measured: within 1 month after end of treatment
prognostic factors
Measured: within 1 month after end of treatment
progression free survival
Measured: within 1 month after end of treatment
overall survival
Measured: within 1 month after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Chronic Lymphoproliferative DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Studio Linfomi
- Sponsor type
- University, hospital or other
- Investigators
- Emilio Iannitto, MD, Study chair, Gruppo Italiano Studio LinfomiFortunato Morabito, MD, Study director, Gruppo Italiano Studio LinfomiStefano Luminari, MD, Principal investigator, Gruppo Italiano Studio Linfomi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224769
- Sponsor's protocol ID
- RETRO-BENDA
- Status last verified
- Oct 2010
- First submitted
- 7 Oct 2010
- Last updated
- 21 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01224769
- Acronym / sponsor ID
- RETRO-BENDA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Gruppo Italiano Studio LinfomiUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bendamustine +/- rituximab | – | Drug: bendamustine +/- rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with relapsed or refractory chronic lymphoproliferative disorders treated with bendamustine +/- rituximab
Key inclusion criteria (3 listed)
- patients with relapsed or refractory chronic lymphoproliferative disorders
- salvage treatment with bendamustine +/- rituximab
- age ≥ 18 years
Key exclusion criteria (1 listed)
- previous treatment with bendamustine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bendamustine +/- rituximab | Drug | bendamustine +/- rituximab |
Primary outcome
overall response rate
Time frame: within 1 month after end of treatment
4 secondary outcomes
grade III and IV (NCI Common Toxicity Criteria) adverse events
Time frame: within 1 month after end of treatment
prognostic factors
Time frame: within 1 month after end of treatment
progression free survival
Time frame: within 1 month after end of treatment
overall survival
Time frame: within 1 month after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Chronic Lymphoproliferative Disorders, run by Gruppo Italiano Studio Linfomi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (time frame: within 1 month after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2010.