An Italian Experience on Grade 3b Follicular Lymphoma

• Conditions: Grade 3b Follicular Lymphoma

• Registration Number: NCT02927717
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-28
• Status Verified: 2016-10
• Study Start: 2016-10
• Study First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Study First Posted: 2016-10-07
• Last Update Posted: 2016-10-07
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Overall Survival	Date of last follow-up for at least 2 years (up to 15 years)	Time to last follow-up or death