NCT01609036

Brief Summary

This observational study will evaluate the safety and efficacy of MabThera/Rituxan (rituximab) in previously untreated patients with follicular lymphoma. Data will be collected for 3 years

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

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

May 29, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1 month

First QC Date

May 29, 2012

Last Update Submit

November 1, 2016

Conditions

Lymphoma, Follicular

Outcome Measures

Primary Outcomes (1)

  • Safety: Incidence of adverse events

    3 years

Secondary Outcomes (3)

  • Progression-free survival

    3 years

  • Event-free survival

    3 years

  • Overall survival

    3 years

Study Arms (1)

Cohort

Eligibility Criteria

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

Patients with stage III-IV follicular lymphoma

You may qualify if:

  • Adult patients, \>/=18 years
  • Patients with previously untreated follicular lymphoma (stage III-IV) according to the approved summary of product characteristics (SPC)

You may not qualify if:

  • Contraindications to MabThera/Rituxan therapy according to the approved SPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Athens, 106 76, Greece

Location

Unknown Facility

Athens, 115 27, Greece

Location

Unknown Facility

Pátrai, 265 00, Greece

Location

Unknown Facility

Thessaloniki, 570 10, Greece

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

May 31, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

GR(4)