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

Grade 3b Follicular Lymphoma

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

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.

Sponsor

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

Principal Investigator: Barbara Botto, MD, AOU Citta 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)