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FL3b-Oss-2015: An Italian Experience on Grade 3b Follicular Lymphoma

Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)
Overall Status
Unknown status
CT.gov ID
NCT02927717
Collaborator
(none)
60
Enrollment
7
Duration (Months)

Study Details

Study Description

Brief 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) criteria.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    An Italian Experience on Grade 3b Follicular Lymphoma
    Study Start Date :
    Oct 1, 2016
    Anticipated Primary Completion Date :
    Apr 1, 2017
    Anticipated Study Completion Date :
    May 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate [End of front-line treatment (evaluated from diagnosis up to 30 months)]

      Number of patients who achieve Complete Response or Partial Response after treatment

    Secondary Outcome Measures

    1. Progression Free Survival [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

    2. Overall Survival [Date of last follow-up for at least 2 years (up to 15 years)]

      Time to last follow-up or death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Investigators

    • Principal Investigator: Barbara Botto, MD, AOU Città della Salute e della Scienza di Torino

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Barbara Botto, MD, Azienda Ospedaliera Città della Salute e della Scienza di Torino
    ClinicalTrials.gov Identifier:
    NCT02927717
    Other Study ID Numbers:
    • FL3b-Oss-2015
    First Posted:
    Oct 7, 2016
    Last Update Posted:
    Oct 7, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Barbara Botto, MD, Azienda Ospedaliera Città della Salute e della Scienza di Torino
    Grade 3b Follicular Lymphoma
    2016 WHO Criteria
    Front-line treatment
    Rituximab
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Follicular

    Study Results

    No Results Posted as of Oct 7, 2016