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

Lymphoma, Follicular Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01609036
• Other study ID #: ML22236
• Status: Terminated
• Phase: N/A
• First received: May 29, 2012
• Last updated: November 1, 2016
• Start date: October 2012
• Est. completion date: November 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		3 years	No
Secondary	Progression-free survival		3 years	No
Secondary	Event-free survival		3 years	No
Secondary	Overall survival		3 years	No