An Italian Experience on Grade 3b Follicular Lymphoma

Grade 3b Follicular Lymphoma Clinical Trial

— FL3b-Oss-2015  

Official title:

An Italian Experience on Grade 3b Follicular Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02927717
• Other study ID #: FL3b-Oss-2015
• Status: Not yet recruiting
• Phase: N/A
• First received: September 28, 2016
• Last updated: October 6, 2016
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: October 2016
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Barbara Botto, MD
• Phone: +390116334553
• Email: bbotto[@]cittadellasalute.to.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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) criteria.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Grade 3b Follicular Lymphoma
• Lymphoma
• Lymphoma, Follicular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate	Number of patients who achieve Complete Response or Partial Response after treatment	End of front-line treatment (evaluated from diagnosis up to 30 months)	No
Secondary	Progression Free Survival	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)	No
Secondary	Overall Survival	Time to last follow-up or death	Date of last follow-up for at least 2 years (up to 15 years)	No