NCT02927717

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

October 7, 2016

Status Verified

October 1, 2016

Enrollment Period

6 months

First QC Date

September 28, 2016

Last Update Submit

October 6, 2016

Conditions

Grade 3b Follicular Lymphoma

Keywords

Grade 3b Follicular Lymphoma2016 WHO CriteriaFront-line treatmentRituximab

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Progression Free Survival

    From first response to last follow-up for at least 2 years (up to 15 years)

  • Overall Survival

    Date of last follow-up for at least 2 years (up to 15 years)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient with grade 3b Follicular Lymphoma treated with Rituximab containing chemotherapy as front-line treatment

You may qualify if:

  • Diagnosis of grade 3b Follicular Lymphoma
  • Age \> 18 years
  • Front-line treatment with Rituximab containing chemotherapy
  • Availability of histological sample for central review

You may not qualify if:

  • Other lymphoma diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Barbara Botto, MD

    A.O.U. Città della Salute e della Scienza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Botto, MD

CONTACT

+390116334553bbotto@cittadellasalute.to.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 28, 2016

First Posted

October 7, 2016

Study Start

October 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

October 7, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

paper publication