Non-Hodgkin Lymphoma Transformed RecurrentFLT-Oss-2015NCT02927756
Italian Multicenter Retrospective Observational Study on Transformed Lymphomas
An observational study of Non-Hodgkin Lymphoma Transformed Recurrent, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
Study purpose is to evaluate treatment outcome and survival in patient with aggressive lymphomas transformed from Follicular Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma Transformed Recurrent
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2017to Jun 2018
- 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: Adult patient with histologically confirmed diagnosis of Transformed Follicular Lymphoma
Who may be able to join
- Histologically confirmed transformed Follicular Lymphoma
- Age > 18 years
- Histological transformation between January 2002 and December 2014
- Availability of data about treatment and outcome
Who cannot join
- Other lymphoma diagnosis
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
SC Ematologia - AOU Città della Salute e della Scienza di Torino
Torino, 10126
Barbara Botto, MD, +390116331, bbotto@cittadellasalute.to.it
About this study
Study purpose is to evaluate treatment outcome and survival in patient with aggressive lymphomas transformed from Follicular Lymphoma.
- Keywords
- Non-Hodgkin Lymphoma Transformed Recurrent, Discordant Lymphomas, Composite Lymphomas, Follicular Lymphoma, Aggressive Lymphoma
- Medical subject headings
- Composite Lymphoma, Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Time from last response to nearest relapse or follow-up
Measured: From first response to last follow-up for at least 2 years (up to 15 years)
Overall Survival
Time to last follow-up or death
Measured: Date of last follow-up for at least 2 years (up to 15 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startNov 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma Transformed RecurrentStudies 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Botto, A.O.U. Città della Salute e della Scienza
- Investigators
- Barbara Botto, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927756
- Sponsor's protocol ID
- FLT-Oss-2015
- Acronym
- FLT-Oss-2015
- Status last verified
- Nov 2017
- First submitted
- 28 Sep 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: paper publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Italian Multicenter Retrospective Observational Study on Transformed Lymphomas
- ClinicalTrials.gov ID
- NCT02927756
- Acronym / sponsor ID
- FLT-Oss-2015 / FLT-Oss-2015
- Keywords
- Non-Hodgkin Lymphoma Transformed Recurrent, Discordant Lymphomas, Composite Lymphomas, Follicular Lymphoma, Aggressive Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- Nov 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 7 Oct 2016 (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.
Study purpose is to evaluate treatment outcome and survival in patient with aggressive lymphomas transformed from Follicular Lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient with histologically confirmed diagnosis of Transformed Follicular Lymphoma
Key inclusion criteria (4 listed)
- Histologically confirmed transformed Follicular Lymphoma
- Age > 18 years
- Histological transformation between January 2002 and December 2014
- Availability of data about treatment and outcome
Key exclusion criteria (1 listed)
- Other lymphoma diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression Free Survival
Time frame: From first response to last follow-up for at least 2 years (up to 15 years)
Time from last response to nearest relapse or follow-up
Overall Survival
Time frame: Date of last follow-up for at least 2 years (up to 15 years)
Time to last follow-up or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Individual participant dataSharing planned: Yes. paper publication
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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.
Barbara Botto, MD principal investigator
A.O.U. Città della Salute e della Scienza
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 Non-Hodgkin Lymphoma Transformed Recurrent, run by A.O.U. Città della Salute e della Scienza 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 4 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Botto, MD (+390116334553, bbotto@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: From first response to last follow-up for at least 2 years (up to 15 years)). The study lists 2 primary outcomes in all. 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 24 Nov 2017.