- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02927717
An Italian Experience on Grade 3b Follicular Lymphoma (FL3b-Oss-2015)
October 6, 2016 updated by: Barbara Botto, Azienda Ospedaliera Città della Salute e della Scienza di Torino
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 Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Barbara Botto, MD
- Phone Number: +390116334553
- Email: bbotto@cittadellasalute.to.it
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patient with grade 3b Follicular Lymphoma treated with Rituximab containing chemotherapy as front-line treatment
Description
Inclusion Criteria:
- Diagnosis of grade 3b Follicular Lymphoma
- Age > 18 years
- Front-line treatment with Rituximab containing chemotherapy
- Availability of histological sample for central review
Exclusion Criteria:
- Other lymphoma diagnosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
End of front-line treatment (evaluated from diagnosis up to 30 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
Time to last follow-up or death
|
Date of last follow-up for at least 2 years (up to 15 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Barbara Botto, MD, AOU Città della Salute e della Scienza di Torino
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
April 1, 2017
Study Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
September 28, 2016
First Submitted That Met QC Criteria
October 6, 2016
First Posted (Estimate)
October 7, 2016
Study Record Updates
Last Update Posted (Estimate)
October 7, 2016
Last Update Submitted That Met QC Criteria
October 6, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FL3b-Oss-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
paper publication
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Grade 3b Follicular Lymphoma
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Seagen Inc.TerminatedLymphoma, Large B-Cell, Diffuse | Follicular Lymphoma, Grade 3b | Lymphoma, B-cell | Lymphoma, Follicular, Grade 3bUnited States
-
Pell Bio-Med Technology Co., Ltd.RecruitingDiffuse Large B Cell Lymphoma | Primary Mediastinal Large B Cell Lymphoma | Large B-cell Lymphoma | Follicular Lymphoma Grade 3B | Follicular Lymphoma Grade 3ATaiwan
-
City of Hope Medical CenterNational Cancer Institute (NCI)WithdrawnRecurrent Grade 1 Follicular Lymphoma | Recurrent Grade 2 Follicular Lymphoma | Recurrent Grade 3 Follicular Lymphoma | Recurrent Mantle Cell Lymphoma | Recurrent Marginal Zone Lymphoma | Refractory B-Cell Non-Hodgkin Lymphoma | Recurrent Small Lymphocytic Lymphoma | Recurrent B-Cell Non-Hodgkin... and other conditionsUnited States
-
Ruijin HospitalUnknownDiffuse Large B-cell Lymphoma | Follicular Lymphoma Grade 3BChina
-
Pell Bio-Med Technology Co., Ltd.RecruitingDiffuse Large B Cell Lymphoma | Primary Mediastinal Large B Cell Lymphoma | Large B-cell Lymphoma | Follicular Lymphoma Grade 3B | Follicular Lymphoma Grade 3ATaiwan
-
University of WashingtonRecruitingDiffuse Large B-Cell Lymphoma | High Grade B-Cell Lymphoma | Grade 3b Follicular LymphomaUnited States
-
National Cancer Institute (NCI)Celgene CorporationActive, not recruitingAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedAnn Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage II Grade 3 Contiguous Follicular Lymphoma | Ann Arbor Stage II Grade 3 Non-Contiguous... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedStage III Grade 1 Follicular Lymphoma | Stage III Grade 2 Follicular Lymphoma | Stage III Grade 3 Follicular Lymphoma | Stage IV Grade 1 Follicular Lymphoma | Stage IV Grade 2 Follicular Lymphoma | Stage IV Grade 3 Follicular LymphomaUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGrade 3a Follicular Lymphoma | Ann Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage III Grade 3 Follicular Lymphoma | Ann Arbor Stage...United States