An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Lymphoma

An Observational Phase IV Non Interventional Study in Patients With Advanced Follicular Lymphoma (III-IV) Evaluating the Safety of Maintenance Therapy With Rituximab After 8 Cycles of Rituximab in Combination With Chemotherapy as Induction Therapy in Previously Untreated Patients in Greece.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01609036

Enrollment

Registered

2012-05-31

Start date

2012-10-31

Completion date

2012-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Follicular

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	3 years

Secondary

Measure	Time frame
Progression-free survival	3 years
Event-free survival	3 years
Overall survival	3 years

Countries

Greece

Outcome results