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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609036
First received: May 29, 2012
Last updated: April 7, 2014
Last verified: April 2014

May 29, 2012
April 7, 2014
October 2012
November 2012   (final data collection date for primary outcome measure)
Safety: Incidence of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01609036 on ClinicalTrials.gov Archive Site
  • Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Event-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with stage III-IV follicular lymphoma

Lymphoma, Follicular
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01609036
ML22236
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP