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: September 22, 2014
Last verified: September 2014
  Purpose

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


Condition
Lymphoma, Follicular

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3
Study Start Date: October 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with stage III-IV follicular lymphoma

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609036

Locations
Greece
Athens, Greece, 115 27
Athens, Greece, 106 76
Patras, Greece, 265 00
Thessaloniki, Greece, 570 10
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01609036     History of Changes
Other Study ID Numbers: ML22236
Study First Received: May 29, 2012
Last Updated: September 22, 2014
Health Authority: Greece: Ministry of Health and Welfare

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 29, 2014