An Observational Study of First-Line Maintenance MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01684865
First received: September 11, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This prospective observational study will evaluate the safety and efficacy of fi rst-line MabThera/Rituxan (rituximab) maintenance therapy in patients with folli cular non-Hodgkin's lymphoma. Patients initiated on MabThera/Rituxan maintenance therapy according to the standard of care and in line with the current summary of product characteristics will be followed for a maximum of two years or until disease progression occurs.


Condition
Non-Hodgkin's Lymphoma, Lymphoma, Follicular

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Event free rate [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (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 follicular non-Hodgkin's lymphoma receiving first-line Rituximab maintenance treatment

Criteria

Inclusion Criteria:

  • Adult patients (according to local regulation)
  • Patients receiving first-line MabThera/Rituxan maintenance treatment for follicular non-Hodgkin's lymphoma according to the local label and who give consent to take part within 4 weeks after commencing treatment

Exclusion Criteria:

  • Contraindications according to the Summary of Product Characteristics
  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: NCT01684865

Contacts
Contact: Reference Study ID Number: ML27993 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Macedonia, The Former Yugoslav Republic of
Recruiting
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
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: NCT01684865     History of Changes
Other Study ID Numbers: ML27993
Study First Received: September 11, 2012
Last Updated: July 7, 2014
Health Authority: Macedonia: Ministry of Health Pharmaceuticals Bureau

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014