Grade 3b Follicular LymphomaFL3b-Oss-2015NCT02927717
An Italian Experience on Grade 3b Follicular Lymphoma
An observational study of Grade 3b Follicular Lymphoma, run by A.O.U. Città della Salute e della Scienza.
Trial summary
Study purpose is to evaluate baseline clinical data, outcome after front-line Rituximab containing chemotherapy and survival in patients with grade 3b Follicular Lymphoma. Also an histological central review is planned in order to re-assess baseline diagnosis according to new 2016 World Health Organization (WHO)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade 3b Follicular Lymphoma
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to May 2017
- 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 grade 3b Follicular Lymphoma treated with Rituximab containing chemotherapy as front-line treatment
Who may be able to join
- Diagnosis of grade 3b Follicular Lymphoma
- Age > 18 years
- Front-line treatment with Rituximab containing chemotherapy
- Availability of histological sample for central review
Who cannot join
- Other lymphoma diagnosis
Trial locations and contacts
No sites are listed yet.
About this study
Study purpose is to evaluate baseline clinical data, outcome after front-line Rituximab containing chemotherapy and survival in patients with grade 3b Follicular Lymphoma.
Also an histological central review is planned in order to re-assess baseline diagnosis according to new 2016 World Health Organization (WHO) criteria.
- Conditions
- Grade 3b Follicular Lymphoma
- Keywords
- Grade 3b Follicular Lymphoma, 2016 WHO Criteria, Front-line treatment, Rituximab
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Number of patients who achieve Complete Response or Partial Response after treatment
Measured: End of front-line treatment (evaluated from diagnosis up to 30 months)
Secondary outcomes (2)
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 startOct 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grade 3b Follicular LymphomaStudies 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
- 60 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
- NCT02927717
- Sponsor's protocol ID
- FL3b-Oss-2015
- Acronym
- FL3b-Oss-2015
- Status last verified
- Oct 2016
- First submitted
- 28 Sep 2016
- Last updated
- 7 Oct 2016
- 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 7 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Italian Experience on Grade 3b Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT02927717
- Acronym / sponsor ID
- FL3b-Oss-2015 / FL3b-Oss-2015
- Conditions
- Grade 3b Follicular Lymphoma
- Keywords
- Grade 3b Follicular Lymphoma, 2016 WHO Criteria, Front-line treatment, Rituximab
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2017 (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 baseline clinical data, outcome after front-line Rituximab containing chemotherapy and survival in patients with grade 3b Follicular Lymphoma.
Also an histological central review is planned in order to re-assess baseline diagnosis according to new 2016 World Health Organization (WHO) criteria.
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 grade 3b Follicular Lymphoma treated with Rituximab containing chemotherapy as front-line treatment
Key inclusion criteria (4 listed)
- Diagnosis of grade 3b Follicular Lymphoma
- Age > 18 years
- Front-line treatment with Rituximab containing chemotherapy
- Availability of histological sample for central review
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
Overall Response Rate
Time frame: End of front-line treatment (evaluated from diagnosis up to 30 months)
Number of patients who achieve Complete Response or Partial Response after treatment
2 secondary outcomes
Progression Free Survival
Time frame: From first response to last follow-up for at least 2 years (up to 15 years)
Overall Survival
Time frame: Date of last follow-up for at least 2 years (up to 15 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2016.
- Individual participant dataSharing planned: Yes. paper publication
Related trials for Grade 3b Follicular Lymphoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
Active, not recruitingPhase 3
A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL)
Diffuse Large B-cell Lymphoma
Active, not recruitingPhase 1/2
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
RecruitingPhase 2
Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
Grade 3b Follicular Lymphoma, High Grade B-Cell Lymphoma
Active, not recruitingPhase 2/3
Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma
Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma
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
Questions about this trial
What is this clinical trial studying?
An observational study of Grade 3b Follicular Lymphoma, run by A.O.U. Città della Salute e della Scienza.
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 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall Response Rate (time frame: End of front-line treatment (evaluated from diagnosis up to 30 months)). 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 7 Oct 2016.